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Medical Device made Easy Podcast
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Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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332 episodes
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Content provided by Monir El Azzouzi. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Monir El Azzouzi or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
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332 episodes
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×In this episode, Mark Rogovoi will share his experience with Certification bodies. He had the experience working for them and working for manufacturers so this is really something that can show you the inside. You will see the good of working with them but also the bad. Mark will be really honest and share some stories, and you’ll see that this is not all good. Who is Mark Rogovoi ? Mark Rogovoi brings 18 years of international experience in Manufacturing Quality across Poland, Russia, Kazakhstan, Spain, and Israel. He is a seasoned QMS professional proficient in ISO 9001 and ISO TS 16949 standards, with a strong Lean 6 Sigma background as a certified Green Belt. As a Lead Auditor for ISO 9001, he has conducted both internal and external audits. Mark also holds an EMBA from the Stockholm School of Economics and a master’s degree in Electrotechnical Engineering from Saint-Petersburg State Electrotechnical University. 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 Mark Rogovoi LinkedIn: https://www.linkedin.com/in/markrogovoi/ 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 The post The good, the bad and the ugly of certification bodies appeared first on Medical Device made Easy Podcast . hamza benafqir…
Medboard EU EU MDR and IVDR article 10a – Discontinuation of Supply: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0745-20250110#art_10a EU IVDR transition periods – Visual: https://health.ec.europa.eu/document/download/ff7fa114-c539-46b3-9066-4bfbb306e9de_en?filename=timeline_ivdr_en.pdf EUDAMED EMDN: UPDATE or not to UPDATE – MDCG 2024-2 Rev 1 and 2021-12 Rev 1 : https://health.ec.europa.eu/document/download/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf MDCG 2024-2: https://health.ec.europa.eu/document/download/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf MDCG 2021-12: https://health.ec.europa.eu/document/download/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf Contact points of National Authorities – Bookmark them in case: https://health.ec.europa.eu/document/download/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf EU Battery 2023/1542 – Guidance issued by EU commission: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:C_202500214 Swiss Maintenance of Medical Devices – Guidance for Hospitals: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/reprocessing—maintenance/maintenance.html UK timeline for UKCA – Be ready for 2030: https://assets.publishing.service.gov.uk/media/6718b88738149ce9d09e3894/Infographic_-_Devices_transition_timeline.pdf UK Post-Market Surveillance – Implementation and Template of PSUR: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation https://assets.publishing.service.gov.uk/media/67813b39363ac763c8ede498/Medical_devices_periodic_safety_update_report__PSUR__formatting__1_.pdf PMS Guidance: https://www.gov.uk/government/publications/medical-devices-periodic-safety-update-report-psur/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-periodic-safety-update-reports PMS Requirements: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-requirements-for-medical-devices-summary-of-main-changes PMS Obligations per device type: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/post-market-surveillance-pms-obligations-by-medical-device-type TUK Vigilance Reporting – Field Safety notices and Example of incidents: https://www.gov.uk/government/publications/medical-devices-examples-of-reportable-incidents FSN: https://www.gov.uk/guidance/effective-field-safety-notices-fsns-guidance-for-manufacturers-of-medical-devices#full-publication-update-history Devices for cardiac ablation: https://www.gov.uk/government/publications/reporting-adverse-incidents-devices-for-cardiac-ablation Joint Replacement implant: https://www.gov.uk/government/publications/reporting-adverse-incidents-joint-replacement-implants#full-publication-update-history Intraocular lenses: https://www.gov.uk/government/publications/reporting-adverse-incidents-intraocular-lenses Insulin pumps and meter systems: https://www.gov.uk/government/publications/reporting-adverse-incidents-insulin-pumps-and-meter-systems UK guide for IVD – Learn before to re-learn: https://assets.publishing.service.gov.uk/media/67863a313ef063b15dca0f47/Guidance_on_the_regulation_of_IVD_medical_devices_in_GB.pdf Training EU MDR training – Green Belt Certification Program: https://school.easymedicaldevice.com/course/gb33/ Rest of the World: Laboaratory Developed Tests FAQ – Learn all about LDTs: https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/definitions-and-general-oversight-laboratory-developed-tests-faqs and https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/medical-device-reporting-complaints-and-corrections-removals-reporting-laboratory-developed-tests How to apply your dossier in Australia – Full guidance by TGA: https://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/australian-regulatory-evidence-options-medical-device-application/tga-conformity-assessment-certification/application-instructions-conformity-assessment Malaysia guidance for HIV Self-test – Placement on the Malaysia Market: https://www.mda.gov.my/index.php/documents/ukk/3480-final-gd-placement-of-hiv-self-test-kit-in-malaysia-market-2nd-edition-pdf/file Import Medical Device for Personnal Use in Malaysia – What means Personal use? https://portal.mda.gov.my/index.php/documents/ukk/3468-draft-public-comment-gd-importation-of-medical-device-for-personal-use-second-edition-updated-2025-pdf/file Alert by Philippines for Product registration – Engaging consultants is not encouraged: https://www.fda.gov.ph/wp-content/uploads/2025/01/FDA-Advisory-No.2025-0033-.pdf Saudi Arabia clearance of Medical Devices – For trainings or conferences: https://www.sfda.gov.sa/sites/default/files/2025-01/Guide%20to%20Conditions%20and%20requirements%20for%20Clearing%20food%2C%20Medical%20devices%2C%20and%20cosmetics%20for%20exhibitions%2C_1.pdf China Medical Device Regulations Round-up 2024 – Cisema.com video: 2024 Round-Up of China Medical Device regulations India update classification lists – List available: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTIzNDI= Podcast Episode 318 – How to register a Medical Device in South Africa – Khanysile Nkuku : https://podcast.easymedicaldevice.com/318-2/ Episode 319 – How to perform your PMS for a Drug-Device Combination – Joan D’Souza: https://podcast.easymedicaldevice.com/319-2/ Episode 320 – Top 5 common NCs on an ISO 13485 audit: https://podcast.easymedicaldevice.com/320-2/ Episode 321 – 6 Tips to grow as a QA RA Manager: https://podcast.easymedicaldevice.com/321-2/ The post Medical Device News January 2025 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, I will give you 6 tips to help you grow as a QA RA Manager. These are coming from my own experience so maybe they are not exactly reflecting your situation but this may help you understand some logic. 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. 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 The post 6 Tips to Grow as a QA RA Manager appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Adam Isaac Rae will share with us is TOP 5 common NCs during an ISO 13485 audit. He will go through all the clauses and for each of them he will bring his TOP issue. So after that the exercise will be for you to check if this issue can be identified within your QMS. So good research to you. Who is Adam Isaacs Rae ? 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 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 Adam Isaacs Rae LinkedIn: https://www.linkedin.com/in/adam-isaacs-rae/ Top ISO 13485 Nonconformances: https://easymedicaldevice.com/top-iso-13485-nonconformances-and-how-to-prevent-them/ 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 The post TOP 5 common NCs on an ISO 13485 audit appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Joan D’Souza will help us to do our PMS the right way when we have to deal with a Drug-Device Combination. We will review what is a Drug-Device Combination or DDC and then identify some case studies. She will also provide us with the guidances that we should follow. Who is Joan D’Souza ? I have experience in pharmacovigilance, regulatory affairs, medical writing, and law (JD, licensed to practice law in the state of Minnesota, US). I offer future employers dedication, a passion for learning, and a longstanding insight into the pharmaceutical sector. I am driven, hard-working, enthusiastic, and always willing to take on new responsibilities. Therapeutic areas: vaccines, endocrinology, immunology, rare diseases, gastroenterology, autoimmune diseases, cardiovascular diseases, dermatology, medical devices, drug-device combinations, oncology, and neurology. 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 Joana de Souza LinkedIn: https://www.linkedin.com/in/drjoanswatidsouza/ 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 The post How to perform your PMS for a Drug-Device Combination? appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Khanyisile Nkuku will share with us the way companies can register an medical device in South Africa today and also what change will happen in a near future. She will also talk to us about the participation of South Africa to the AMDF – Africa Medical Device Forum, where pilot project started to issue a continental approval within 22 countries. So this may help register more easily in Africa. Who is Khanyisile Nkuku? Ms Khanyisile Nkuku In her current role as a Medical device & IVD Registration Officer at the South Africa Competent Authority (SAHPRA) , she contributes her expertise in the assessment and registration of medical devices & IVD’s in South Africa to promote medical device & IVD access on a global scale, with a particular focus on African countries. She holds a Bachelor of Pharmacy honours degree ,a Master’s in Pharmacy administration & Policy Regulation , and is currently busy with Masters in Business Administration in Healthcare Leadership . She is an experienced Pharmacist with successful background in medical device & IVD regulations and regulatory system strengthening. Having great strength in policy advocacy, policy development, policy implementation and compliance. She partakes in the International medical device regulatory forum (IMDRF) working groups and Africa medical device forum (AMDF) technical mainly the MDA-TC ( Medical device Assessment Technical committee member. She is further a committee member for two South African Bureau of Standards (SABS) Technical committees . 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 Khanyisile Nkuku LinkedIn: http://linkedin.com/in/khanyisile-nkuku-975663a9 SAHPRA Website: https://www.sahpra.org.za/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 The post How to register a Medical Device in South Africa? appeared first on Medical Device made Easy Podcast . hamza benafqir…
Stefan bolleininger will share with us information regarding Artificial intelligence and MDR. This presentation happened during Medica 2024. So if you have any questions you can ask ok the comments. Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”. Link: Stefan bolleininger LinkedIn: https://www.linkedin.com/in/stefan-bolleininger-3a717028/ 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 The post Medica: AI & MDR FLIP THE COIN appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Monir El Azzouzi will summarize 2024 for Easy Medical Device and share projects for 2025. He will explain the situation in Consulting, Representation, eQMS , eIFU project, Medtech Conferences, Podcasts Episodes, Topra Awards and all the future projects in 2025. 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. 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 The post Easy Medical Device Great Summary 2024 appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Adnan Ashfaq will share with us the major pitfalls he experienced when dealing with Medical Device startups. He will provide his advice so you can be successful and already know some issues that you may encounter as a Startup Who is Adnan Asfaq? Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Pharmi Med in 2011 and has since been supporting Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has been working with start-up companies and multinationals in developing new products since 1999. With regulations tightening up, especially in Europe, Pharmi Med is enabling and trying to help simplify the compliance conundrum to ensure manufacturers reach their desired market and stay in the market. 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: Adnan Ashfaq LinkedIn: https://www.linkedin.com/in/adnan-ashfaq-44478121/ Simplimedica website: https://simplimedica.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 The post What are the major pitfalls of Startups in Medical Devices? appeared first on Medical Device made Easy Podcast . hamza benafqir…
MEDBOARD: https://www.medboard.com/ EUROPE TEAM-NB high level position – Making Medical Devices Safer and Faster: https://www.team-nb.org/wp-content/uploads/2024/12/Team-NB-HighLevel-Strategy- PositionPaper-20241130.pdf MDCG 2024-15 – Reporting Medical Device Trials Made Easy!: https://health.ec.europa.eu/document/download/0e076d19-62dc-4ff9-83f2-be6072a45993_en? filename=mdcg_2024-15_en.pdf EMA activities on Combination products – Reminder on Drug-Device assessment.: https://www.ema.europa.eu/en/documents/presentation/presentation-sme-info-day- session-4-ema-activities-medical-devices_en.pdf MDCG 2024-16 Interruption or Discontinuation – For certain devices: https://health.ec.europa.eu/document/download/b431b10f-8512-4f47-9191-e1b84b2f9a27_en? filename=mdr_qna-article10a_mdr-ivdr_en.pdf and annex https://health.ec.europa.eu/document/download/b4a7dea7-ae73-4e13-a8a8-11dcd2678d38_en?filename=md_mdc-2024-16 _annex_en.pdf Joint Paper from 9 Member states – Council of the European Union: https://data.consilium.europa.eu/doc/document/ST-15380-2024-INIT/en/pdf Reduction of Administrative Burdens Centralization of System Management to the EMA Predictable Certification Procedures Enhanced Coordination and Support Impact Assessment and Resource Allocation MDCG 2024-14 Master UDI-DI – Contact lenses: https://health.ec.europa.eu/document/download/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14 _en.pdf Master UDI-DI Assignment Labelling Requirements Vigilance Reporting EUDAMED Registration Implementation Timeline Artificial Intelligence in Medical Devices . Joint publication Team NB and IG-NB: https://www.team-nb.org/wp-content/uploads/2024/11/Team-NB-PositionPaper-AI-in-MDQuestionnaire-V1-20241125.pdf Gradual Roll-out of EUDAMED – Be ready to start: https://health.ec.europa.eu/document/download/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf Spain application for in-house devices – For hospitals: https://www.aemps.gob.es/informa/la-aemps-pone-en-marcha-una-nueva-aplicacion-para-la-comunicacion-de-fabricacion-de-productos-sanitarios-in-house-por-hospitales/ SMARTEYE Eqms Smarteye: https://eqms-smarteye.com/ EVENTS Arab Health – January 27 to 30th, 2025: https://medtechconf.com/event/total-radiology-conference/ TRAINING Mini-Course MDR: https://easymedicaldevice.com/resource/resource-medical-device-regulation/mini-course-mdr/ ROW US – Some healthcare software are not devices – WARNING: https://www.fda.gov/media/184083/download?attachment Administrative support in healthcare settings. Promoting healthy lifestyles without direct links to disease management. Serving as electronic patient records without interpreting or analyzing data. Transferring, storing, converting, or displaying medical data without interpretation. Providing limited clinical decision support to healthcare providers without interpreting clinical tests or device data. US – PCCP Final guidance – Submit a PCCP with your submission: https://www.fda.gov/media/166704/download • Webinar January 14, 2025 – https://www.fda.gov/medical-devices/cdrhnew-news-andupdates/webinar-final-guidance-marketing-submission-recommendations-predetermined-change-control-plan?utm_source=FDALinkedin South Korea Guidance – Enhancing Medical Device Safety!: https://www.mfds.go.kr/law/board/boardDetail.do?menuKey=29&brdId=data0011&seq=15564 Australia – Guidelines for Medical Devices – Bookmark the link: https://www.tga.gov.au/resources/resource/reference-material/australian-regulatory-guidelines-medical-devices- argmd Australia – Submit Custom-made device – Guidance step-by-step: https://www.tga.gov.au/resources/resource/user-guide/how-submit-custom-made-medical-device-notification Malaysia – Advertisement application – Approve your Advertising: https://www.mda.gov.my/index.php/industry/medical-device-advertisements/medical-device-advertisement PODCAST How MDR and IVDR code can save you money? Stefan Bolleininger: https://podcast.easymedicaldevice.com/309-2/ Is FMEA bad for your Risk Management? Rod Beuzeval: https://podcast.easymedicaldevice.com/310-2/ How to build the perfect Quality Management System? https://podcast.easymedicaldevice.com/311-2/ IEC 60601-1-8 How to test your Medical Device Alarms? Beat Keller https://podcast.easymedicaldevice.com/312-2/ PCCP – The magic tool for planned changes in the US? Maria Diez: https://podcast.easymedicaldevice.com/313-2/ 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 The post Medical Device News December 2024 Regulatory Update appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Maria Diez from CMGMedDev is explaining to us the PCCP tool for SaMD and why it can help a lot. We will also review US vs EU regarding changes to SaMD. Who is Maria Diez? María Diez is a seasoned expert in Quality Assurance (QA) and Regulatory Affairs (RA) for medical devices and in vitro diagnostic devices (IVDs), with over a decade of professional experience in the field. Holding a Ph.D. in Biochemistry and Molecular Biology, María has specialized in developing and maintaining Quality Management Systems (QMS) in compliance with standards such as ISO 13485, ISO 14971, and IEC 62304. She also brings extensive expertise in ensuring compliance with international medical device regulations, including those of the FDA, MDR, and IVDR. Additionally, María has significant experience in integrating advanced technologies, such as Artificial Intelligence (AI) and cybersecurity, into medical device software (MDSW) and Software as a Medical Device (SaMD). Currently, María serves as a QA/RA Consultant at CMG MedDev, where she assists medical device manufacturers in bringing safe and effective products to market. Her expertise includes preparing technical documentation for CE marking, managing regulatory submissions for non-European markets, and helping companies navigate evolving global regulatory landscapes. María’s passion for education and innovation drives her active participation in industry conferences, where she shares her knowledge on AI-based MDSW/SaMD development and her experiences as a PRRC during the certification process. 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 Maria Diez LinkedIn: www.linkedin.com/in/maría-diez-zaera-46460323 CMGMedDev website: https://www.linkedin.com/company/cmgmeddev/posts/ PCCP guidance US: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial https://www.fda.gov/regulatory-information/search-fda-guidance-documents/predetermined-change-control-plans-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 The post PCCP – The Magic tool for SaMD in the US? appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Beat Keller from SMDC in Switzerland will help us to setup the right tests for your alarm systems. And you’ll see that it is not so obvious. Who is Beat Keller? Beat Keller is the founder and Managing Director of SMDC which supports medical devices to bring compliant medical devices on market quickly. Next to his experience in the medical device industry first as a software engineer, as project manager and later on as a regulatory affairs and quality manager, he is also member of different standardization working groups in Switzerland, on European level and internationally at IEC. 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 Beat Keller LinkedIn: https://www.linkedin.com/in/beat-keller/ SMDC website: https://www.smdc.ch IEC 60601-1-8 Alarm System: https://webstore.iec.ch/en/publication/59648 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 The post IEC 60601-1-8 How to test your Medical Device alarms? appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Monir El Azzouzi will help you build the perfect Quality Management System. He will give you his recipe to start the creation of a QMS and show you step by step what you should do. 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 Blog: Does your Quality Manual look like that? https://easymedicaldevice.com/quality-manual/ Video: How to get ISO 13485 certified? https://www.youtube.com/watch?v=paT2oR0uwjg ISO 13485 standard: https://knowledge.bsigroup.com/products/medical-devices-quality-management-systems-requirements-for-regulatory-purposes?version=tracked Blog: ISO 13485 Mandatory procedures: https://easymedicaldevice.com/iso-13485-procedure/ 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 The post How to build the perfect Quality Management System? appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Rod Beuzeval will explain the reason why FMEA is maybe not the right method for your Risk Management per ISO 14971. So, check this and tell us if you agree. Who is Rod Beuzeval? Rod has 25+ years of experience in the medical device and pharmaceutical industry. He has expertise in regulatory strategy, technical documentation, QMS systems, standards compliance, clinical evaluation, risk management, project management, and remediation activities. Rod has worked for a notified body, conducted audits against EN ISO 13485, and supported reviews of technical documentation for medical device manufacturers in Europe. His experience includes Class I, II, and III devices, software as a medical device, drug delivery devices, IVDs, and active implantable medical devices. 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 Leap Compliance LinkedIn: www.linkedin.com/company/leap-compliance Leap Compliance website: www.leapcompliance.com ISO 14971 Standard: https://www.evs.ee/en/evs-en-iso-14971-2019 Video: What is ISO 14971: https://www.youtube.com/watch?v=5C2CzApjI_U Podcast: Why Risk Management is important for Medical Devices: https://podcast.easymedicaldevice.com/207-2/ eQMS for Risk Management: https://eqms-smarteye.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 The post Is FMEA bad for your Risk Management? appeared first on Medical Device made Easy Podcast . hamza benafqir…
In this episode, Stefan Bolleininger will explain you can save money on your MDR or IVDR submission just by choosing the right MDR or IVDR code and by following some of his advice. Who is Stefan Bolleininger? Stefan Bolleininger is a key opinion leader and speaker for the medical device regulation MDR in Europe. He founded the be-on-Quality GmbH consulting agency to passionately support manufacturers during CE approvals or FDA approvals. This support covers the full chain of quality and regulatory requirements: Implementation, maintenance, audits, assessments, and inspections. In the area of “Risk Management and Usability for Medical Devices and Medical Networks”, he holds a teaching assignment at the Technical University of Nuremberg and the VDI Technical Committee “Quality Assurance for Software in Medical Devices”. 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 Stefan Bolleininger Linkedin: https://www.linkedin.com/in/stefan-bolleininger-3a717028/ BeOnQuality Website: https://www.be-on-quality.com/ MDCG 2019-14 – MDR code: https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2019_14_mdr_codes_en_0.pdf MDCG 2021-14 – IVDR code: https://health.ec.europa.eu/system/files/2021-07/md_mdcg_2021-14-guidance-ivdr-codes_en_0.pdf EMDN Code: https://webgate.ec.europa.eu/dyna2/emdn/ Notified Body database NANDO : https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/by-legislation eQMS for Medical Devices: https://eqms-smarteye.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 The post How MDR and IVDR code can save you money? appeared first on Medical Device made Easy Podcast . hamza benafqir…
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