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Medical Device made Easy Podcast

Medical Device made Easy Podcast

Written by: easymedicaldevice
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About this listen

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.

Monir El Azzouzi Economics Leadership Management & Leadership
Episodes
  • How to Remediate a Design History File (DHF)

    How to Remediate a Design History File (DHF)
    Jan 22 2026

    Design History File (DHF) remediation is rarely planned — yet it is a recurring challenge for many medical device manufacturers, especially during audits, inspections, acquisitions, or regulatory framework changes.

    In this podcast episode, we provide a structured and practical discussion on:

    The definition and purpose of a DHF

    Key differences between FDA QMSR and ISO 13485 requirements

    How the DHF concept is addressed within ISO 13485

    When DHF remediation becomes unavoidable

    Typical causes of remediation, including accumulated DHF debt

    How to remediate a DHF without creating new compliance risks

    Common pitfalls and practices to avoid

    How to define a realistic and defensible remediation strategy

    Regulatory communication considerations with:

    National Competent Authorities

    Notified Bodies

    This episode is based on an article developed by Wega Informatik AG and is intended to help MedTech professionals approach DHF remediation in a controlled, transparent, and compliant way.

    If you are responsible for design controls, quality systems, or regulatory compliance, this episode will help you avoid costly mistakes and build confidence in your remediation approach.

    Links

    Richie Christian Linkedin: https://www.linkedin.com/in/christianrichie/

    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
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    32 mins
  • Medical Device News January 2026 Regulatory Update

    Medical Device News January 2026 Regulatory Update
    Jan 15 2026
    Medboard: https://www.medboard.com/EuropeEMD Mag Issue 3 - For QA RA people: https://easymedicaldevice.com/emd-mag/EU to simplify MDR and IVDR - Proposal ongoing: https://health.ec.europa.eu/document/download/25e7ea7c-cab3-40cf-86d9-d11f5e7744d8_en?filename=md_com_2025-1023_act_en.pdf - https://ec.europa.eu/commission/presscorner/api/files/document/print/en/qanda_25_3078/QANDA_25_3078_EN.pdf - https://ec.europa.eu/commission/presscorner/api/files/attachment/882087/FACTSHEET%20medical%20devices%20final%20(1).pdfTeam NB Position Paper on Annex VII - Not agreeing all EU Proposal: https://www.team-nb.org/wp-content/uploads/2025/12/Team-NB-PositionPaper-Annex-VII-V1-20251216.pdfMDCG 2025-9 Learn Breakthrough Devices BtX - Guidance for innovative products: https://health.ec.europa.eu/document/download/edca94c7-62ab-4dd5-8539-2b347bd14809_en?filename=mdcg_2025-9.pdfInfographic: https://www.linkedin.com/posts/melazzouzi_medtech-mdr-ivdr-activity-7414590943179202560-jbxH?utm_source=share&utm_medium=member_desktop&rcm=ACoAAABZ07ABDocaBMTLJo8bsl8V3bgNSBIiZuIMDCG 2025-10 on PMS - Learn how to do it with this guidance: https://health.ec.europa.eu/document/download/a9ad86b7-1b8e-4bae-beb4-48b2b3ed2f05_en?filename=mdcg_2025-10_en.pdfNotified Body Malta Conformity Assessment - 52nd Notified Body for MDR: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications?organizationRefeCd=SIMS_INPUT_282916&filter=notificationStatusId:1 ServicesEasyIFU - Manage your eIFU and Labels: https://easyifu.com SwitzerlandSwissdamed registration deadline - July 1st 2026: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/medizinprodukte-datenbank/swissdamed-informationen/frist-produktregistrierung-in-swissdamed.html - https://swissdamed-webinar.ch/#E402A0UKMHRA Price changing -: More cost for manufacturers: https://www.gov.uk/guidance/register-medical-devices-to-place-on-the-market#fees RoWFDA: How to use Real World Evidence - Guidance Document offered: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devicesAustralia: Preparing for UDI and AusUDID - Checklist for preparation available: https://www.tga.gov.au/sites/default/files/2025-12/preparing-for-udi-in-australia-checklist_0.pdf PodcastPodcast Nostalgia - What was discussed lastly: Episode 367 - From Engineer to Clinical Evaluation Expert - Florian Tolkmitt: https://podcast.easymedicaldevice.com/367-2/Episode 368 - Simplifying EU MDR IVDR with Adam Isaacs Rae: https://podcast.easymedicaldevice.com/368-2/Episode 369 - Last Podcast of the Year: https://podcast.easymedicaldevice.com/369-2/Episode 370 - Verification & Validation with Aaron Joseph: https://podcast.easymedicaldevice.com/370-2/
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    35 mins
  • Verification & Validation Explained — A Practical Conversation with Aaron Joseph

    Verification & Validation Explained — A Practical Conversation with Aaron Joseph
    Jan 7 2026

    Verification & Validation (V&V) plays a central role in ensuring that medical devices are safe, effective, and compliant — yet it remains one of the most challenging phases for many teams.

    In this podcast episode, we sit down with Aaron Joseph, medical device development expert and author of the well-known article “Top 10 V&V Fails”, to explore why V&V so often becomes a source of stress — and how teams can do better.

    Throughout the discussion, we cover:

    A clear, simple explanation of Verification vs. Validation

    Why V&V must span the entire development lifecycle

    How poor requirements create downstream V&V failures

    The risks of starting V&V planning too late

    How to simplify test methods without losing rigor

    Practical strategies for handling failed tests

    How to think about traceability without fear

    The future of V&V as software and AI become more prevalent

    This episode is designed to educate, demystify, and inspire QA/RA professionals, engineers, and MedTech leaders looking to build stronger, more resilient development processes.

    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

    Aaron Joseph Linkedin: https://www.linkedin.com/in/ajosephprofile/

    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
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    42 mins
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