Medical Device made Easy Podcast

easymedicaldevice

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

  1. Automatisation of your QA RA job with AI 

    -4 J

    Automatisation of your QA RA job with AI 

    Artificial Intelligence is reshaping the world of Quality and Regulatory Affairs. In this podcast episode, Hatem Rabeh joins to demystify how AI can be used — and where it must be handled carefully. We discuss: The reality behind “AI replacing QA/RA jobs” Key tools: n8n, Make, Zapier, OpenAI, and OpenFDA Building automation workflows for regulatory monitoring and documentation Managing data privacy, confidentiality, and local vs cloud solutions The cost, setup time, and risks of AI hallucination How to use AI safely and ethically in regulated environments 👉 By the end, you’ll know how to build smart workflows that save time, ensure compliance, and keep human oversight where it matters most. 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

    1 h 6 min
  2. US Government Shutdown – What FDA can still be doing?

    30 OCT.

    US Government Shutdown – What FDA can still be doing?

    US Government Shutdown – What the FDA Can Still Be Doing? When the U.S. government experiences a shutdown, the consequences ripple across every industry — but for medical device manufacturers, the uncertainty can be alarming. In this article, Regulatory Expert Rob Packard explores what happens to the U.S. Food and Drug Administration (FDA) during a shutdown, and how it affects global manufacturers. You’ll learn: Which FDA activities continue, and which are suspended How submissions like 510(k), PMA, and De Novo are impacted What happens to clinical trials, recalls, and ongoing investigations Whether this situation has happened before and how long it could last How companies can prepare and what contingency actions to take 💡 Rob also shares practical advice for manufacturers seeking FDA support during this period, as well as insights into how his team can assist in maintaining compliance and communication continuity. If you’re part of the medical device ecosystem — this is essential reading. Tags: FDA, Medical Devices, Regulatory Compliance, Quality Management, US Government Shutdown, Rob Packard, Clinical Trials 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

    29 min
  3. Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance

    23 OCT.

    Real-World Evidence (RWE): How to Use It Right for FDA and EU MDR Compliance

    Real-World Evidence (RWE) is transforming how regulators evaluate medical devices — but many manufacturers still struggle to use it correctly. In this episode, we break down what RWE really means, how it differs between the FDA and the EU MDR, and how you can design a compliant, global strategy that turns data into regulatory strength. You’ll learn: What qualifies as Real-World Data (RWD) and Real-World Evidence (RWE) How the FDA integrates RWE into premarket submissions (510(k), De Novo, PMA) How EU MDR uses RWE through PMCF and PMS The key differences in approach between the two regions A practical 5-step roadmap to build a compliant RWE strategy Common pitfalls (bias, poor traceability, privacy issues) — and how to avoid them 💡 Whether you’re in Regulatory Affairs, Clinical Affairs, or Quality Assurance, this episode gives you a clear framework to make Real-World Evidence a competitive advantage, not a compliance headache. 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

    38 min
  4. Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)

    16 OCT.

    Clinical Evidence under EU MDR – Why So Many Dossiers Fail (and How to Fix It)

    Since the implementation of EU MDR 2017/745, clinical evidence has become one of the biggest challenges for medical device manufacturers — and a major source of Notified Body nonconformities. This episode breaks down the root causes behind failed submissions and offers a practical framework to fix them: Understanding the shift from MDD to MDR (Article 61 & Annex XIV) Why weak Clinical Evaluation Plans (CEPs) lead to rejection How to generate and analyze real, device-specific clinical data Integrating Post-Market Clinical Follow-up (PMCF) into your PMS system Maintaining a “living” Clinical Evaluation Report across the device lifecycle 👉 By following this checklist, you’ll not only pass your next review but also strengthen your evidence strategy for long-term compliance. 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

    34 min
  5. Highlights from La Rentrée du DM 2025

    9 OCT.

    Highlights from La Rentrée du DM 2025

    The La Rentrée du DM 2025 conference brought together regulators, manufacturers, and industry experts to discuss the evolving landscape of European and global medical device regulation. Main themes included: Updates on EU MDR/IVDR and new regulatory initiatives in France Structured dialogue with Notified Bodies and the harmonization of technical documentation Post-market discontinuation and the importance of anticipation for patient safety Eco-design and sustainability, bridging healthcare and environmental responsibility Software and AI in clinical investigations, and the use of real-world data Global market access – EU vs US pathways and MDSAP recognition Technical deep dives into ISO 13485, biocompatibility, usability, and cybersecurity The consensus was clear: regulatory pressure is increasing, but collaboration, innovation, and anticipation remain the keys to success. 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 Site web larentreedudm: https://www.larentreedudm.com Linkedin poste: https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381678647151112192-WQqX?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQhttps://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381670070097297408-80sP?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381641922739609600-HXhq?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-easymedicaldevice-regulatoryaffairs-activity-7381639827718447104-SQs-?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevice-regulatoryaffairs-easymedicaldevice-activity-7381629520535060480-kJ0p?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ https://www.linkedin.com/posts/melazzouzi_medicaldevices-regulatoryaffairs-easymedicaldevice-activity-7381602405030711296-aHcv?utm_source=share&utm_medium=member_desktop&rcm=ACoAADkVV4QBTohHEk1IW3vOF7GCRT4JjGn0ggQ 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

    36 min
  6. Medical Device News OCTOBER  2025  Regulatory Update

    1 OCT.

    Medical Device News OCTOBER 2025 Regulatory Update

    Medboard Europe TToo much Incomplete Tech File - Let's explain to you how to do it: https://www.team-nb.org/wp-content/uploads/2025/09/Team-NB-PositionPaper-BPG-IVDR-V2-20250903.pdf 2025/1920 on Master UDI-DI - Not only lenses but also Spectacle frames and Ready-to-wear: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202501920 Borderline manual Update -  New products included: https://health.ec.europa.eu/document/download/71a87df8-5ca1-4555-b453-b65bdf8de909_en?filename=md_borderline_manual_en.pdf red blood cell additive solutions containing adenine dual action cream with menthol and capsaicin Lactose tablets for vaginal use microabrasion dental stain removers medical examination table covers Mobile sterile air system   EU asks your feedback on EU MDR and IVDR - Enjoy reading some 100 feedbacks: https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14808-Medical-devices-and-in-vitro-diagnostics-targeted-revision-of-EU-rules_en Switzerland Swissdamed Technical Documentation - XML upload: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/swissdamed-technical-documents.html Business Rules Swissdamed: https://www.swissmedic.ch/dam/swissmedic/en/dokumente/medizinprodukte/mep_urr/bw630_40_002e_pu_swissdamed_business_rules.pdf.download.pdf/BW630_40_002e_PU_swissdamed_Business_Rules.pdf   UK UK PMS guidance for Report - Template available: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/requirements-of-the-manufacturers-pms-system PMSR Template: https://www.gov.uk/government/publications/medical-devices-standardised-format-for-the-post-market-surveillance-report   Magazine Issue 1: Sept/Oct 2025 - Next one will come November 2025: https://easymedicaldevice.com/emd-mag/ Events Medtech Conf events - Be listed on the MAP: https://medtechconf.com/events-map-2/ EasyIFU Free trial for eIFU with EASYIFU - Compliant EU 2025/1234: https://easyifu.com ROW US FDA Computer System Assurance - SOP offered on the show notes: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-system-software-0 Malaysia affiliate member of MDSAP - What does it change?:  https://portal.mda.gov.my/index.php/announcement/1636-malaysia-is-now-mdsap-medical-device-single-audit-program-mdsap-member Australia Essential Principles Checklist Update -: Update the templates V1.2: https://www.tga.gov.au/resources/resource/checklists/essential-principles-checklist Egypt guidance to import your devices - Medical Devices, Accessories, IVD: All type of devices: https://edaegypt.gov.eg/media/lafopofx/1-regulatory-guideline-of-issuance-of-import-approvals-of-all-types-of-medical-devices_gd.pdf Medical Equipment and Accessories: https://edaegypt.gov.eg/media/fltnd1qc/4-regulatory-guideline-of-issuing-import-approvals-for-medical-equipment-and-their-accessories_gd.pdf IVD: https://edaegypt.gov.eg/media/e2rf4qg5/2-regulatory-guideline-of-the-procedures-and-rules-of-obtaining-import-approvals-for-iaboratory-and-diagnostic-equipment-gd.pdf   Podcast Episode 353: Cybersecurity in Medical Devices: What QA/RA must do Today: https://podcast.easymedicaldevice.com/353-2/ Episode 354: From Surgeon to CEO: Building Neurogyn AG: https://podcast.easymedicaldevice.com/354-2/ Episode 355: Postmarket Surveillance for SaMD and AI: https://podcast.easymedicaldevice.com/355-2/ Easy Medical Device Service Support for Consulting (QA RA projects) Support for Authorized Representative and Market Access Integration to an eQMS 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

    33 min
  7. Post-Market Surveillance for Software and AI Devices

    24 SEPT.

    Post-Market Surveillance for Software and AI Devices

    Post-Market Surveillance for Software & AI Devices – A QA/RA Guide Software evolves with updates. AI models may even change with real-world data. That makes Post-Market Surveillance (PMS) for digital medical devices very different from traditional hardware. In this article, based on the podcast episode, we cover: How PMS differs for software, cloud, and AI-based devices Usage monitoring & anomaly detection through dashboards and KPIs Revalidation of updates and retrained AI algorithms Regulatory frameworks: EU MDR/IVDR, FDA’s PCCP, IMDRF guidelines Supplier and infrastructure considerations A step-by-step PMS workflow for QA/RA teams Real-world case study on AI performance drift 👉 We conclude with a practical checklist to help QA/RA teams ensure compliance while keeping patients safe. 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

    24 min
  8. From Surgeon to CEO: Building NEUROGYN AGProfessor MarcPossover’s Journey

    18 SEPT.

    From Surgeon to CEO: Building NEUROGYN AGProfessor MarcPossover’s Journey

    From Surgeon to CEO: Prof. Marc Possover’s Inspiring Journey in Medical Innovation The journey from a successful surgical career to the leadership of a medical company is far from ordinary. Yet for Prof. Marc Possover, this evolution felt like a natural extension of his life’s mission: to improve patient outcomes and expand access to advanced treatments in pelvic neurosurgery. In this exclusive episode of the Medical Device Made Easy Podcast, host Monir El Azzouzi invites Prof. Possover to share his story—one that blends clinical excellence, entrepreneurial vision, and a deep commitment to education. A Career Built on Medical Breakthroughs Prof. Possover is internationally recognized as a pioneer in neuropelveology, a specialty dedicated to treating complex pelvic nerve disorders. Over the years, he has developed innovative procedures that offer hope to patients suffering from chronic pain and dysfunctions once considered untreatable. But his ambition has always reached beyond the operating room. By founding his own medical company, he sought to transform groundbreaking surgical techniques into accessible, reproducible therapies that benefit patients worldwide. Why a Surgeon Became a CEO Moving from the precision of surgery to the strategic demands of business might seem like a dramatic shift, but for Prof. Possover it was a continuation of his mission. Becoming a CEO meant taking responsibility not only for individual patients but for the future of the treatments themselves. Leadership allowed him to guide product development, secure resources, and create an ecosystem where new therapies could flourish well beyond his own practice. As he explains in the podcast, “At some point I will retire—or die—but what will remain are the colleagues I trained.” His decision to lead a company ensures that his techniques will survive and continue to evolve, creating impact that outlasts any single career. Patient Education as a Driving Force Throughout the conversation, Prof. Possover emphasizes the vital role of patient education. When patients are aware of new treatment options, they actively seek qualified specialists, creating a natural demand for innovation. This patient-driven movement pressures the medical community to adopt cutting-edge solutions and ensures that life-changing therapies reach those who need them most. By offering information sessions and open discussions, he empowers patients to become advocates for their own health—transforming the doctor–patient relationship into a true partnership. Building a Global Legacy Through Training Prof. Possover’s passion for teaching is at the heart of his work. Through the International School of Neuropelveology (ISNP), he trains surgeons from around the world in these advanced procedures. Every surgeon he educates becomes a multiplier of knowledge, capable of treating patients in regions far beyond his own reach. This dedication reflects a philosophy that medicine’s greatest achievements are collective. A breakthrough is only meaningful if it can be shared, replicated, and improved upon by future generations. Lessons for Medical Professionals and Entrepreneurs This conversation is more than an inspiring personal story—it is a roadmap for anyone seeking to combine medicine, innovation, and business. Clinical expertise can fuel entrepreneurship when paired with strategic thinking. Patient awareness accelerates adoption, creating a powerful feedback loop between innovation and demand. Education builds permanence, ensuring that treatments survive beyond the careers of their pioneers. Whether you are a surgeon curious about entrepreneurship, a MedTech innovator looking for guidance, or a healthcare professional eager to create lasting change, Prof. Possover’s journey demonstrates that the skills learned in medicine—discipline, precision, and empathy—are the very qualities that can drive successful leadership. In this podcast, Monir El Azzouzi and Prof. Marc Possover invite you to reflect on the future of healthcare. Their discussion shows that true medical progress lies not only in discovering new treatments, but also in ensuring that knowledge is shared, patients are informed, and innovations continue to thrive long after their creators have left the stage.

    1 h 1 min

Notes et avis

4,8
sur 5
9 notes

À propos

My name is Monir El Azzouzi and I am a Medical Device Expert specialized in Quality and Regulatory affairs. And on this podcast I will help you place compliant medical devices on the market. For that I will share with you my knowledge or the one of others through discussion or interviews. I will invite experts in the area to tell you what you can do or the challenges you may encounter.

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