EUDAMED is the European Database for Medical Devices. In this episode Richard Houlihan will be my guest and will explain to us the situation regarding EUDAMED. For the moment this database is not finished, so should you use it? We will also review the timeline and help you understand what you should do now. Don’t miss that episode as EU MDR 2017/745 and IVDR 2017/746 asks you to register your company, your products in this database. Who is Richard Houlihan? Richard Houlihan is an international speaker and guest university lecturer on EUDAMED. His time running the European Commission IT teams developing EUDAMED has given him unrivalled insights into how EUDAMED affects the MedTech industry. This EUDAMED experience and his 28 years in IT give him a real advantage when helping companies prepare for EUDAMED, FDA GUDID, and other regulatory submissions.   His company EirMed with the website eudamed.com provides EUDAMED regulatory submission software solutions to help Manufacturers large and small including full project management, training, an EUDAMED mobile search app, and support to help Manufacturers, Importers, European authorised reps, and Distributors meet their EUDAMED obligations. To date, Richard and his team have trained over a thousand people on EUDAMED and helped hundreds of companies with EUDAMED consultancy and their regulatory data submissions to EUDAMED.   Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Link: Richard Houlihan LinkedIn: https://www.linkedin.com/in/richard-houlihan/ EUDAMED.Com website: https://eudamed.com/ EUDAMED database link: https://ec.europa.eu/tools/eudamed/#/screen/home EUDAMED registration page: https://webgate.ec.europa.eu/eudamed/landing-page#/ EUDAMED and Germany: https://www.bfarm.de/EN/Medical-devices/Overview/Europe-and-EUDAMED/_node.html EMDN Code Website: https://webgate.ec.europa.eu/dyna2/emdn/ Meeting Minute EUDAMED timeline: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=48063&fromExpertGroups=3565 Playground: https://webgate.training.ec.europa.eu/eudamed-play Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

In this second part of this podcast serie on Team-Prrc interviews. we have 3 additional guests. Don't miss the first one where we also got great interviews. In this episode, we will interview - Bassil Akra about the Team-PRRC event and why you should come. This will happen again November 16th and 17th. - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company - Elena Kyria on the way a recruiter should work to find a suitable PRRC for your company - Elem Ayne, the Team-PRRC presidente who will explain to us more about the event and how this first session went. So don't miss the next opportunity to meet everyone at the Team-PRRC event in Strasbourg - France on November 16th and 17th. You'll be able to create a great network. Links from the Video Bassil Akra Linkedin: https://www.linkedin.com/in/bassil-akra-akrateam/ Elena Kyria Linkedin: https://www.linkedin.com/in/elenakyria/ Elem Ayne Linkedin: https://www.linkedin.com/in/elemayne/ Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Within this video you will see 4 interviews on the PRRC role. First one with Piero Costa where we will talk about the role of a PRRC within the different economic operators The second one with Erik Vollebregt where we will review the role of a PRRC and liability The third one with Ronald Boumans where we will explain how to behave to be a PRRC And the last one with Christopher Kipp from BVMed on the PRRC role in Germany with the already existing safety officer. Don’t miss the next Team-PRRC event November 16-17 2023 in Strasbourg. Links Piero Costa LinkedIn Page: https://www.linkedin.com/in/pierocosta1980 Erik Vollebregt LinkedIn Page: https://www.linkedin.com/in/erikvollebregt/ Ronald Boumans LinkedIn Page: https://www.linkedin.com/in/ronald-boumans/ Christopher Kipp Linkedin Page: https://www.linkedin.com/in/christopher-kipp-b16ba71b1/ Team-PRRC Event: https://www.team-prrc.eu/page/1111392-presentation Medical Device: All about the role of PRRC: https://www.youtube.com/watch?v=RCBYA1wLQLU Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

EU o MDR and IVDR communication Survey • EU MDR transition • Q&A implementation of MDR extension 2023/607: https://health.ec.europa.eu/system/files/2023-07/mdr_proposal_extension-q-n-a.pdf • Flowchart to decision on the extended MDR transitional period: https://health.ec.europa.eu/document/download/2d29bd99-8523-4c13-bbf5-cc36fcecea93_en?filename=md_devices-art120_flowchart.pdf o Team-NB: New MDR Transition Timeline and Notified Body Capacity: https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf • Blog Post - Erik Vollebregt . Can we fix/improve the MDR and the IVDR? : https://medicaldeviceslegal.com/2023/08/29/can-we-fix-improve-the-mdr-and-the-ivdr/   • Team-NB: Transfer agreement :https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-TransferAgreement-V1-20230811.pdf • Notified Bodies situation :https://health.ec.europa.eu/document/download/3d407427-fad0-498a-b1ef-2db28c9f4423_en?filename=notifiedbodies_overview_en.pdf • EMA consultation: https://www.ema.europa.eu/en/documents/other/questions-answers-consultation-procedure-european-medicines-agency-notified-bodies-ancillary_en.pdf Training offered: • Vigilance Reporting: https://school.easymedicaldevice.com/course/vigilance-reporting-eu-legislation/ •Audit readiness: https://school.easymedicaldevice.com/course/etraining-audit-readiness/ • Green Belt: https://school.easymedicaldevice.com/course/gb26/ UK: o CE Marking recognition: https://www.gov.uk/government/news/ce-marking-recognition-for-medical-devices-and-in-vitro-diagnostics?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=70128116-5d7a-4e60-89d6-99e578f8a33b&utm_content=immediately • Ronald Boumans article: https://www.linkedin.com/posts/ronald-boumans_ukca-maring-for-medical-devices-and-ivds-activity-7092405961541185536-bfRY?utm_source=share&utm_medium=member_desktop • Guardian article: https://www.theguardian.com/commentisfree/2023/aug/04/business-brexit-safety-mark-red-tape-?mibextid=Zxz2cZ • Guardian article: https://www.theguardian.com/politics/2023/aug/08/left-in-limbo-by-brexit-safety-mark-chaos?mibextid=Zxz2cZ   o 3 new UK Approved bodies :https://www.gov.uk/government/news/three-new-uk-approved-bodies-to-certify-medical-devices-announced-by-the-mhra • Approved Body list: https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies   TGA: Webinar : The new Medical devices Vigilance Program- Information for medical device Sponsors in •Australia: https://www.tga.gov.au/resources/event/webinars/new-medical-devices-vigilance-program-information-session-medical-device-sponsors-australia • UDI: https://www.tga.gov.au/resources/event/webinars/unique-device-identification-webinar-18-project-checkpoint-what-we-know-and-what-you-can-do-get-involved   Canada: o Pre-market guidance for Machine learning-enabled : https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/pre-market-guidance-machine-learning-enabled-medical-devices.html USA: o Off-the-Shelf Software :https://www.fda.gov/media/71794/downloadSaudi Arabia: o ISO 13485 for manufacturers & supplies facilities : https://www.sfda.gov.sa/sites/default/files/2023-08/MD-Quality13485.pdf eQMS: o SmartEye : https://smart-eye.io Conferences o MEDXD - Berlin Germany September 26 and 27- : https://medtechx.digital/ • Afrisummit - Cairo Egypt : https://www.pharmaregafrisummit.com/meddev/ • MEDICA - Dusseldorf Germany : https://www.medica-tradefair.com/ • Team-PRRC - Strasbourg France : https://www.team-prrc.eu/page/1111392-presentation Podcast to listen : • Medical Misfits episode: How to join a Tech Startup as a Medical Student: https://www.medicalmisfits.com/zoe-lee/ • The Medtech Podcast by Karandeep Badwal: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3 • The Med-Tech Talent Lab with Mitch Robbins: https://open.spotify.com/show/4b6r5OPbgsS6DqhCZuAFG2• Life Science 360 with Harsh Thakkar: https://www.lifesciencespod.com/2079900 • State of Medtech with Omar Khateeb: https://open.spotify.com/show/5NVrQLfLk0EXDeKDdX7BB6 Podcast Nostalgia • Who should be on your Risk Management Dream Team with Naveen Agarwal:  https://podcast.easymedicaldevice.com/243-2/ • Hire your QA RA employee with no Budget with Mitch Robbins: https://podcast.easymedicaldevice.com/244-2/ • Why you should automate your Software Validation with Christophe Girardey and Virginie Rochat? https://podcast.easymedicaldevice.com/245-2/ • What are the Acceptance Criteria for your Clinical Evaluation with Cesare Magri. https://podcast.easymedicaldevice.com/246-2/ • How to perform your Cleaning Validation in practice? With Enrico Allegra: https://podcast.easymedicaldevice.com/247-2/

Medical Devices that are reusable should be cleaned. But the user is not a professional of your product so he needs to receive some instruction on how to clean it. In this episode of the podcast we will explain to you what is cleaning validation and also talk about microbiology, electrical device cleaning, Notified Body issues… So let’s listen to Enrico Allegra from TestLabs who will share with us his experience. Who is Enrico Allegra? Enrico has over 10 years of experience in regulatory microbiology combining environmental safety with clinical settings as a study director. He graduated with a Bachelor of Science degree in Immunology with Medical Microbiology followed by a master’s degree in Clinical Microbiology from Queen Mary University of London in 2013. During his previous role, he worked extensively in method transfer and development. His work spanned from environmental microbiology to clinical settings. He worked on clinical trials to assess the validity of vaccination against Group B Streptococci in pregnant women. He was strongly involved in the assessment of the safety of agrochemical products such as biocides as well as being the lead scientist for the assessment of antimicrobial susceptibility testing of pre and probiotic products. During his time working in safety assessment, he collaborated on a CRACK-IT sponsored research under the NC3Rs as the lead scientist. The research focused on evaluating the discrimination of toxic and non-toxic chemicals using wax moth larvae Galleria mellonella as model to help reduce, replace, and refine the use of animal models. The research was published for Chemosphere (Elsevier) in May 2018. During the height of the pandemic, he worked on the development of antiviral assays against Coronavirus as well as being part of clinical trial of bacteriophage technology to help fighting secondary infection of cystic fibrosis patients. He is a certified biosafety officer and operates as the Head of Laboratory at Test Labs, a Medical Device testing laboratory. Enrico massively helped developing the facility from an empty canvas to a fully operational ISO 17025:2017 accredited laboratory, in less than 11 months. Leading the microbiology, chemistry and material sciences teams in performing Medical Device testing, he provides expert knowledge combining the experience in method validation and new method development to help customer with reliable and fully validated reports. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links from the Video ■Enrico Allegra LinkedIn: https://www.linkedin.com/in/enrico-allegra-b97751164 ■TestLabs LinkedIn Page: https://www.linkedin.com/company/testlabsuk/ ■TestLabs webpage: https://testlabsuk.com/ Social Media to follow ■ Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi ■ Twitter: https://twitter.com/elazzouzim ■ Pinterest: https://www.pinterest.com/easymedicaldevice ■ Instagram: https://www.instagram.com/easymedicaldevice

We all are afraid of one thing. It is to see our Clinical Evaluation rejected by a Notified Body. Why? Because apparently EU MDR is creating a more restrictive environment for accepting what was acceptable before. So let’s review in this episode the acceptance criteria for your Clinical Evaluation and what kind of surprises you would maybe discover all along the way. For that I have invited Cesare Magri from 4BetterDevices to help us understand this pathway and take the right road at the crosses. Who is Cesare Magri? Cesare has a mixed Background: Physics and Neuroscience, PhD in Informatics. He worked as a biostatistician at Max Planck in Tübingen and started working with medical devices and clinical evaluations in 2013. He founded be-on-Clinical together with Stefan Bolleininger in 2020. And recently, created the CRO 4BetterDevices. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Link: -Cesare Magri Linkedin : https://www.linkedin.com/in/cesare-magri/ 4BetterDevices -LinkedIn Page: https://www.linkedin.com/company/4betterdevices/ -Website 4BetterDevices: https://4betterdevices.com/ Social Media to follow -Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi -Twitter: https://twitter.com/elazzouzim -Pinterest: https://www.pinterest.com/easymedicaldevice -Instagram: https://www.instagram.com/easymedicaldevice

Software validation is key. This is mentioned on different standards, and this is required by the auditors to prove that your software is safe. This is valid for Software as a Medical Device SaMD but also to software used as a quality tool. ISO 13485 is asking you to validate software’s that are used to track quality data.  In this episode, Christophe Girardey and Viriginie Rochat from Wega will explain to us the next level of the software validation which is the automation. Imagine that you can automate your validation and you don’t need to test everything manually. That would save you a lot of time. But what are the benefits or pitfalls of it?   Don’t miss this episode if you are in software development or if you use Software to manage quality data.  Who is Christophe Girardey?  Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.  Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.  Who is Virginie Rochat?  Virginie is leading the Test Automation team at wega, a life science consulting company specialized in digitalization. The Test Automation team is composed of people with a broad range of backgrounds -  from software and testing engineers to QA and Validation specialists - in order to support Pharmaceutical and Medical Device companies when it comes to automate end-to-end testing. With its expertise in user interface test automation tools, wega can support you through the selection of the proper tool based on your needs and infrastructure, validate the tool and then help your teams into the development of automated test cases and provide the necessary experience to support your team to reach compliance in a more efficient way.  Virginie has more than 10 years of experience within pharma laboratories. She has always been keen to automate repetitive tasks and prone to adopt new technologies to improve the efficiency of the business processes, leading her to develop more and more knowledge on informatic and technologies, to bridge the gap between Science and IT.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Article on Test Automation: https://www.wega-it.com/en/automatisierung-von-softwaretests-fuer-nutzeranforderungenChristophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Virginie Rochat Linkedin: https://www.linkedin.com/in/virginie-rochat86/ wega Website : https://www.wega-it.com/  Medical Device: https://www.wega-it.com/en/computer-systems-validation-quality-assurance#medical-device-compliance  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Hiring a new candidate for your team is always a challenge. But how to do that when there is no Budget allocated to it. This is what we will show you in the podcast episode.   Mitch Robbins is a professional recruiter that has its own agency “The Anthony Michael Group”. He is able to help you on your research as he is specialised in QA RA recruitment. But he also knows your pain when your company cannot hire a recruiter for this mission. So, we will review what he proposes to you to be successful regarding this challenge.  Who is Mitch Robbins?  Mitch Robbins is the Founder and Managing Director of The Anthony Michael Group in a suburb of Denver, CO. Mitch and his team at AMG helps organizations (Med-Device, Diagnostics, and Digital Health) to hire the top 15% of Elite Technical Talent in areas like Regulatory Affairs, Quality, Engineering, R&D, Manufacturing and Operations. Mitch, himself, is consistently ranked across the world within the top 1% of Headhunters and has been the choice of the experts to deliver training to both rookies and seasoned recruiters across multiple disciplines on numerous occasions.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Mitch Robbins Linkedin : https://www.linkedin.com/in/mitchrobbins  Linkedin Post: https://www.linkedin.com/posts/mitchrobbins_regulatoryaffairs-hiring-theanthonymichaelgroup-activity-7076976156570243073-kEsY/  Podcast Med-Tech Talent Lab: https://spoti.fi/3LqqubL The Anthony Michael Group website: https://www.theanthonymichaelgroup.com  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

When you look at ISO 13485 or EU MDR or US FDA, they all want to see that you are reducing the risk for your products. But to do that you have to brainstorm and identify those risks. Usually, we follow ISO 14971 for that. But not all of your team is aware of this, and we are now short on time. So, what to do? Draft it by yourself or work with some colleagues. Naveen Agarwal will be sharing with us the best way to collaborate to create a successful Risk Management process. So, let’s listen to that.  Who is Naveen Agarwal?  Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from the University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, a Manager of Quality and Operational Excellence, and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance, and Quality Culture in the Medical Device Industry. In his spare time, he enjoys distance running, community work, and spending time with his family.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Naveen Agarwal Linkedin : https://www.linkedin.com/in/naveenagarwal/ Linkedin Post: https://naveenagarwalphd.substack.com/p/collaboration-is-the-secret-sauce-for-riskmgmt  Achieve Website: https://www.achievexl.com  Let Us Talk Risk Newsletter: https://naveenagarwalphd.substack.com/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services: https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Artificial Intelligence is the actual hot topic that everyone is talking about. A lot of countries are starting to regulate this technology. But what are we talking about. This episode will help you understand AI and also understand what the risks to it are. This is really an interesting topic, but a lot of people are really afraid when we talk about AI. We will try to give you some tips to clarify the situation.  For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies who use Artificial Intelligence for their software.  Who is Christophe Girardey?  Christophe Girardey is Managing Director at Wega, a life science consulting company specializing in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. Wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. Wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.  Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/  Medical Device Compliance: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance  Data Sciences: https://www.wega-it.com/clinical-development-it#data-science  Wega Breakfast: Artificial Intelligence in GxP environments: https://www.youtube.com/watch?v=dCDwEkXd9jU&t=11s  Nature Article (co-authored):  https://www.nature.com/articles/s41582-020-00448-7FDA list of Software with AI: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-enabled-medical-devices? Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Have you ever been to an audit and the auditor is asking you to show them the validation of your Quality Management System software. The first reflex is to say “But I buy it like that so I don’t validate that” and the auditor to say “Ok, then there is a non-conformity to ISO 13485”. I know painful. So let’s review today the way to validate you Quality tools and why this seem so important. For that I have invited Christophe Girardey from Wega to answer my questions as he is helping companies to validate their software. Who is Christophe Girardey? Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development. Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance. Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. Links from the Video Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/ Wega Website : https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance https://www.wega-it.com/computer-systems-validation-quality-assurance Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

I am sure that at a certain point, your company will try to market your medical devices in Saudi Arabia. And now you are looking for the information that will help you to accelerate the registration of the products. In this episode, Ahmed Hendawy from Registitute will help us understand the best strategy to do that. He will explain to us also the similarities between SFDA and EU MDR. So if you are really motivated to register your product within SFDA then this is the right podcast episode for you.  Who is Ahmed Hendawy?  Ahmed is an esteemed leader in the field of healthcare consulting, renowned for his deep expertise in healthcare regulations, market access, and business strategy within the MENA region. As the founder and driving force behind Registitute, Ahmed has established the firm as a premier provider of specialized services in regulatory affairs and market access.  With a distinguished career, including a previous role as the Head of Regulatory Affairs for the MENA region, Ahmed has demonstrated exceptional skill in navigating complex regulations and spearheading successful market entry strategies. Under his visionary guidance, Registitute has garnered a reputation for excellence and innovation in the healthcare consulting landscape.  Registitute stands apart by delivering tailored solutions that address the unique challenges faced by healthcare organizations operating in the MENA region. Ahmed's strategic vision, combined with the expertise of the Registitute team, continues to drive positive change and support healthcare organizations in adapting to the ever-evolving healthcare landscape in the MENA region.  In summary, Ahmed's leadership and Registitute's unwavering commitment to providing exceptional services position them as a trusted partner for healthcare organizations seeking regulatory expertise and market access support in the MENA region.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Ahmed Hendawy Linkedin :  https://www.linkedin.com/in/ahmed-hendawy-a0a81511a  Registitute LinkedIn: https://www.linkedin.com/company/registitute/   Registitute Website : www.registitute.com   AL TIRYAQ LinkedIn : https://www.linkedin.com/company/al-tiryaq/   SFDA website : www.sfda.gov.sa   SFDA Guidance for Medical Device registration: https://sfda.gov.sa/sites/default/files/2019-12/MDS-G5_1.pdf   Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Sponsor Medboard https://www.medboard.com/ EU Annex XVI transition EU MDR Domino is making more falls. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R1194New Timeline Until 31 December 2029 Cybersecurity and privacy in AI Medical imaging diagnosis https://www.enisa.europa.eu/publications/cybersecurity-and-privacy-in-ai-medical-imaging-diagnosisANSM wants barcode on Field Safety Notice Why not all the other countries https://ansm.sante.fr/actualites/lansm-demande-aux-fabricants-de-dispositifs-medicaux-qui-envoient-un-avis-de-securite-dy-apposer-le-code-barres-des-dispositifs-concernes AEMPS clinical trials involving drugs and medical devices What are the rules if your device is not CE marked https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-procedimiento-a-seguir-en-los-ensayos-clinicos-que-impliquen-medicamentos-y-productos-sanitarios/ Switzerland Medicinal products with a medical device component rules for combination products https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/am-mit-mepkomponente-uebergangsbestimmungen.html UK Implementation of the Future Regulations Should you focus on UKCA? https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations eQMS Do you need an eQMS? Let me introduce Smarteye: https://smart-eye.io So contact info@scube-technologies.com to get a demo USA Premarket notification for Software What is different with Premarket submission for hardware https://www.fda.gov/media/153781/download Webinar - Final Guidance: Content of Premarket Submissions for Device Software Functions  https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/webinar-final-guidance-content-premarket-submissions-device-software-functions-07202023 Australia TGA Use of market authorisation evidence Comparable overseas regulators https://www.tga.gov.au/resources/resource/guidance/use-market-authorisation-evidence-comparable-overseas-regulators-assessment-bodies-medical-devices-including-ivds Malaysia Malaysia rules on EU MDR extension Letter needed https://www.mda.gov.my/announcement/1224-announcement-mda-approach-on-expired-ec-certificate-for-new-registration-and-re-registration-of-medical-device.html Saudi Arabia Saudi Arabia Webinars AI and Classification are on the spotlightArtificial Intelligence and Software Based on Medical Device https://www.sfda.gov.sa/en/workshop/88535 Introducing the Rules for Classifying the Risk of Medical Devices https://www.sfda.gov.sa/en/workshop/88536   Authorized Representative Do you need an Authorized Representative info@easymedicaldevice.com Service: easymedicaldevice.com   Podcast Nostalgia: Podcast Nostalgia What was presented in June. The great Misunderstanding with Florian Tolkmitt: https://podcast.easymedicaldevice.com/236-2/ How to connect Software dev and QARA team with Christophe Girargey Wega: https://podcast.easymedicaldevice.com/237-2/ What should you know on the UKCA extension with Alex Denoon: https://podcast.easymedicaldevice.com/238-2/   Easy Medical Device Support Thanks for your support info@easymedicaldevice.com If you need us to perform your own Regulatory Update, don't hesitate to contact us at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particuarly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

Since Brexit happened, there are multiple waves of changes in the UK. First the UK Responsible Person (which is a hybrid of the EU AR and the EU Importer), then the UKCA requirements, then the new legislation consultation (which will largely harmonise UK law with the MDR and IVDR) and now the extension of the unilateral recognition of CE Marks to allow manufacturers more time to obtain a UKCA marks.   But what all this means for medical devices manufacturers that are already selling in the UK or that plan to sell to the UK. We will review that with Alex Denoon, partner at Bristows.  Don’t forget to check the links below for more details.  Who is Alex Denoon?  Alex advises about Life Sciences regulatory issues all day every day and has been doing so for 30 years.  He enjoys working with clients to devise and implement regulatory strategies throughout the product life cycle of pharmaceuticals, medical devices and IVDs.  Alex has been involved in the development of a number of regulatory frameworks and guidelines. Legal 500 describes Alex as “a straight-talking, commercially astute technology specialist who is always willing to take a view” and who delivers “out-of-the-box solutions”.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Alex Denoon Linkedin : https://www.linkedin.com/in/alexdenoon  Bristows law firm linkedin page: https://www.linkedin.com/company/bristows/  Bristows Website : https://www.bristows.com/  Bristows Blog post on UKCA: https://www.bristows.com/news/will-we-ever-see-a-ukca-mark-for-medical-devices/#:~:text=Currently%2C%20the%20UK's%20medical%20device,conformity%20marking%2C%20the%20UKCA%20mark  UKCA future implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period/implementation-of-the-future-regulations  Infographics timeline: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1164062/Infographic_-_Devices_transition_timeline.pdf  How to register a Medical Device in the UK: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk  Your UK Responsible Person: https://easymedicaldevice.com/uk-responsible-person/  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Software development is really increasing in the Medical Device world and it is maybe important now to discuss about potential gaps that exist between the Software Development team and the Quality and Regulatory Affairs team. Dev team think that they have too much documents to create and quality thinks that the document that the dev team is creating is not really answering the requirements. So how to solve that.  Christophe Girardey from Wega who is dealing with that will tell us why we have this situation and also provide some hints on how this can be resolved.  Who is Christophe Girardey?  Christophe Girardey is Managing Director at wega, a life science consulting company specialized in digitalization. Christophe is responsible for the Quality Assurance Team which supports Pharmaceutical and Medical Device companies when it comes to compliance of Software. wega supports you through the software lifecycle with its expertise in the regulatory field, allowing you to concentrate on your expertise in medical software development. wega can help you to optimize your Software Development processes to reach compliance/quality by design. This includes performing gap analysis, advising on how to implement agile methodologies in a compliant way, configuring and validating the different Software tools to reach an optimal and qualitative Software Development.  Christophe has 15 years of experience within the regulated industry and started his career as Software Developer prior moving to Quality Management activities and can hence best make the bridge between the SW Development and Quality Assurance Team by fostering innovation combined with compliance.  Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Christophe Girardey Linkedin : https://www.linkedin.com/in/christophe-girardey-77ab6027/  Wega Website :  https://www.wega-it.com/  Medical Device: https://www.wega-it.com/computer-systems-validation-quality-assurance#medical-device-compliance  Agile : https://www.wega-it.com/computer-systems-validation-quality-assurance#agility-in-gxp  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Since March 2023 an extension for EU MDR and IVDR was voted by the EU Commission. This podcast episode will remind you the latest news and also answer some frequently asked questions from people. As you may see on the title there are some great misunderstandings, and the objective of today is to clear that out.   For that I have with me Florian Tolkmitt from Pro-Liance and we will try to give you the best content on EU MDR extension.  Who is Florian Tolkmitt?  Florian Tolkmitt is co-founder and CEO of PRO-LIANCE, a consultancy supporting medical device manufacturers with regulatory affairs, clinical affairs and quality management. PRO-LIANCE is based in Germany and serves customers. Florians favorite topics include clinical evaluation, post-market surveillance and risk management and he is also assistant professor at the University of Applied Sciences in Luebeck, Germany, where he teaches Clinical Evaluation to Master students. Apart from that he is the chair of the Regulatory Affairs Professionals Society Chapter in Germany and loves to network and bring the Regulatory Affairs and Quality Community closer together. Last but not least, Florian has a strong interest in Digitalization and is a founding member of the Medical Device Knowledge Unit initiative, that works on an open-source data model for Technical Documentation.   Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  EU MDR extension: https://health.ec.europa.eu/system/files/2023-03/mdr_proposal_extension-q-n-a_0.pdf  Team NB Notified Body confirmation letter: https://www.team-nb.org/wp-content/uploads/members/M2023/Team-NB-PositionPaper-NB-ConfirmationLetterEU2023-607-20230503.docx  Florian Tolkmitt Linkedin : https://www.linkedin.com/in/floriantolkmitt/  Pro-Liance company Site: https://pro-liance.com/  EU 2023/607: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607 Podcast episode EU extension with Erik Vollebregt: https://podcast.easymedicaldevice.com/211-2/  LinkedIn Company: https://www.linkedin.com/company/pro-liance/ Social Media to follow: Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

Sponsor MedBoard: www.medboard.com  EUROPE  Notified Body overview: https://health.ec.europa.eu/system/files/2023-05/notifiedbodies_overview_en.pdf  EU MDR and IVDR consolidated versions  EU MDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20230320  EU IVDR: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0746-20230320  Confirmation letter:  EU Commission: https://health.ec.europa.eu/latest-updates/template-nb-confirmation-letter-framework-regulation-eu-2023607-2023-05-24_en MDCG 2020-3 Significant changes: https://health.ec.europa.eu/latest-updates/update-mdcg-2020-3-rev1-guidance-significant-changes-regarding-transitional-provision-under-article-2023-05-12_en  Update Annex XVI timeline: https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=PI_COM:Ares(2023)3232054  EMDN maintenance project launched: https://www.salute.gov.it/portale/news/p3_2_1_1_1.jsp?lingua=italiano&menu=notizie&p=dalministero&id=6262  Spain: AEMPS and CNCps recognize the need to demonstrate to third parties the validity of expired certificates: https://www.aemps.gob.es/informa/la-aemps-informa-sobre-el-nuevo-procedimiento-del-cncps-para-confirmar-la-validez-de-los-certificados-emitidos-conforme-a-mdd/  Finland: RoHS is also applicable to Medical Devices: https://www.fimea.fi/web/en/-/rohs-act-also-concerns-medical-devices Training:  Green Belt Certification Program June 26th until June 30th. https://school.easymedicaldevice.com/course/gb26  Switzerland  Incident reporting  Incident report for economic operators: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_009d_wl_mdv_vorkommnis_hersteller_mepv.pdf.download.pdf/MU680_20_009e_WL%20Incident%20economic%20operators.pdf  Incident report for users: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_20_008d_wl-vorkommnismeldung-anwender.pdf.download.pdf/MU680_20_008e_WL%20incident%20report%20user.pdf Designation of a Vigilance contact person for hospitals: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/mu680_10_007d_wl-vigilance-kontaktperson-medizinprodukte.pdf.download.pdf/MU680_10_007e_WL%20Vigilance%20contact%20person%20for%20medical%20devices.pdf United Kingdom  New tutorial videos MHRA "How to register medical devices": https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market  New Regulatory Pathway IDAP: https://www.gov.uk/government/news/new-regulatory-pathway-set-to-support-safe-patient-access-to-innovative-medical-technologies Assistive Technology: https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use  Report Adverse incidents for Software: https://www.gov.uk/government/publications/reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system/guidance-for-manufacturers-on-reporting-adverse-incidents-involving-software-as-a-medical-device-under-the-vigilance-system     ROW  Australia: Guidance on applying the Advertising Code rules: https://www.tga.gov.au/how-we-regulate/advertising/how-advertise/advertising-guidance/resources/resource/guidance/guidance-applying-advertising-code-rules  Canada: Consultation on proposed amendments to the Medical Devices Regulations and Food and Drug Regulations:  https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/establishment-licences/medical-devices-compliance-bulletin/consultation-proposed-amendments-medical-devices-food-drug-regulations.html India: CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device        :  https://cdsco.gov.in/opencms/opencms/en/Notifications/Public-Notices/ Egypt: European Parliament Decision of March 2023 regarding the transitional grace periods granted in relation to the application of MDR&IVDR rules and procedures: https://www.edaegypt.gov.eg/ar/%D8%A7%D9%84%D9%85%D8%B1%D9%83%D8%B2-%D8%A7%D9%84%D8%A7%D8%B9%D9%84%D8%A7%D9%85%D9%89/%D8%A7%D9%84%D8%A5%D8%B9%D9%84%D8%A7%D9%86%D8%A7%D8%AA/%D9%82%D8%B1%D8%A7%D8%B1-%D8%A7%D9%84%D8%A8%D8%B1%D9%84%D9%85%D8%A7%D9%86-%D8%A7%D9%84%D8%A3%D9%88%D8%B1%D9%88%D8%A8%D9%8A-%D8%A7%D9%84%D8%B5%D8%A7%D8%AF%D8%B1-%D9%81%D9%89-%D9%85%D8%A7%D8%B1%D8%B3-2023-%D8%A7%D9%84%D8%AE%D8%A7%D8%B5-%D8%A8%D8%A7%D9%84%D9%85%D9%87%D9%84-%D8%A7%D9%84%D8%A5%D9%86%D8%AA%D9%82%D8%A7%D9%84%D9%8A%D8%A9-%D8%A7%D9%84%D9%85%D9%85%D9%86%D9%88%D8%AD%D8%A9-%D8%A8%D8%AE%D8%B5%D9%88%D8%B5-%D8%AA%D8%B7%D8%A8%D9%8A%D9%82-%D9%82%D9%88%D8%A7%D8%B9%D8%AF-%D9%88%D8%A5%D8%AC%D8%B1%D8%A7%D8%A1%D8%A7%D8%AA-mdr-ivdr/  Saudi Arabia Webinar:   Explain The Essential Principles of Safety and Performance for Medical Devices:  https://www.sfda.gov.sa/en/workshop/88451 Risk Management for Medical Devices: ISO 14971 Requirements https://www.sfda.gov.sa/en/workshop/88450  Podcast  Podcast 231: The truth about the UK vs EU situation with Claire Dyson: https://podcast.easymedicaldevice.com/231-2/  Podcast 232: Technical File inconsistencies identified by Notified Bodies with Adam Rae: https://podcast.easymedicaldevice.com/232-2/  Podcast 233: What if your Medical Device company goes bankrupt with Karandeep Badwal: https://podcast.easymedicaldevice.com/233-2/  Podcast 234: How to master Regulatory Intelligence with Ivan Perez Chamorro: https://podcast.easymedicaldevice.com/234-2/  Ask Easy Medical Device . We can help you Contact at info@easymedicaldevice.com Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice Authorized Representative and Importer services:https://easymedicaldevice.com/authorised-representative-and-importer/ Subscribe to our LinkedIn Newsletter: https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7051455462466023424

We all need to keep ourselves up to date. But how to access reliable information and how often should a check be done. This is what we will discuss with Ivan Perez Chamorro from MedBoard. You will get some hints on how to optimize your search.  Regulatory intelligence seems to be a big scary word that people may think it needs a ton of experts to be able to master it. But with digitalization this needs less efforts now. When before you needed to check a lot of journals or visit a lot of country websites, now there are tools that helps you do it quicker. This is mainly the topic of our discussion with Ivan Perez Chamorro from MedBoard.   Who is Ivan Perez Chamorro?  Ivan Perez Chamorro is CEO and Founder of MedBoard, a technology company that organises medical technology information and data, makes it fast accessible to manufacturers and key stakeholders, and it is integrated with breakthrough tools as the Vigilance automation. MedBoard is made up of leading engineers, scientist and medical professionals. This big data platform covers from Regulatory, to Clinical, Market and Technical. Ivan has both strong science and business background, he holds a degree and MSc in Physics from Universidad de Salamanca, and an MBA from IE Business School. Ivan is very active in medical device industry, and he is also part of the TOPRA MedTech SPIN. After having a chronic sports injury while playing basketball, and spending many years in rehabilitation, he decided after physics graduation to work in the medical devices industry. Ivan has lived in different countries and likes travelling, painting, and adventure sports, and has special interest in innovation, entrepreneurship, and technology. MedBoard is not the first project, and Ivan has have a number of entrepreneurship projects in the past, in the medical and outside of medical devices industry. Before Medboard, Ivan had worked for many years within the industry, as an employee of leading medical companies and as a consultant in the areas of product and business development, regulations, and strategy, from operational roles to advising technical and top management. He has broad experience with different types and classes of medical devices and combination products, supporting a variety of organization models, from start-ups to large corporations. Who is Monir El Azzouzi?  Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland.  Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, linkedin Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  Link:  Ivan Perez Chamorro LinkedIn: https://www.linkedin.com/in/ivan-perez-chamorro-804b0b22/ Blog post Medboard:  Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi Twitter: https://twitter.com/elazzouzim Pinterest: https://www.pinterest.com/easymedicaldevice Instagram: https://www.instagram.com/easymedicaldevice

This is really a difficult situation if your company goes bankrupt. But now the idea is what to do regarding the products that are still on the market. You still have some responsibility and the EU MDR is asking you to put in place some process to anticipate that. This is what we will discuss with Karandeep Badwal today. We’ll try to give you some advice on how to overcome this situation. Who is Karandeep Badwal? Karandeep Singh Badwal is an independent Quality & Regulatory consultant within medical devices with a specialism in Software as a Medical Device and Artificial Intelligence having initially started his career within traditional devices working with multi-national companies to small-scale startups. He is also the founder of The MedTech Podcast and regularly makes content around medical devices via LinkedIn and his YouTube channel QRA Medical. Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs. Links from the Video Karandeep Badwal LinkedIn Profil: https://www.linkedin.com/in/karandeepbadwal/The Medtech Podcat: https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3QRA Medical Youtube video: https://www.youtube.com/channel/UC1ygqJO7_HV30XVdHyN-0lg Social Media to follow Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldevice

This week with Adam Rae we will talk about the Technical Files inconsistency that we noticed while working on some projects. Adam will provide his list of issues like Intended purpose, Clinical Evaluation... So if you want to avoid these issues don't miss this episode as they can cost you time and money.  Who is Adam Isaacs Rar?  Chartered quality professional with a Master’s Degree focused in Strategic Quality Management from University of Portsmouth. Demonstrated history of working aerospace & defence, medical device and the construction industry. Skilled in Operations Management, Lean Six Sigma, Failure Mode and Effects Analysis (FMEA), Value Stream Mapping and Supply Chain Management.    Who is Monir El Azzouzi? Monir El Azzouzi is a Medical Device Expert specializing in Quality and Regulatory Affairs. After working for many years with big Healthcare companies, particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people better understand Medical Device Regulations worldwide. He has now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through videos, podcasts, online courses… His company also acts as Authorized Representative for the EU, UK, and Switzerland. Easy Medical Device becomes a one-stop shop for medical device manufacturers that need support on Quality and Regulatory Affairs.   Links:  LinkedIn profile Adam Isaacs Rae:  https://www.linkedin.com/in/adam-isaacs-rae/Easy Medical Device Authorized Representative and Importer service: https://easymedicaldevice.com/authorised-representative-and-importer/  Social Media to follow  Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedical...Instagram: https://www.instagram.com/easymedical...