Medical Device made Easy Podcast Podcast Por easymedicaldevice arte de portada

Medical Device made Easy Podcast

Medical Device made Easy Podcast

De: easymedicaldevice
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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.

This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.

Monir El Azzouzi Economía Gestión y Liderazgo Liderazgo
Episodios
  • Medical Device News APRIL 2026 Regulatory Update

    Medical Device News APRIL 2026 Regulatory Update
    Apr 1 2026
    MedboardSponsor: Medboard: https://www.medboard.com/ EUExtension of WET Class Iib - A new list with new products mentioned: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=PI_COM:C(2026)1809Update your MIR form - Version 7.3.1: https://health.ec.europa.eu/document/download/e8ce9f53-82cb-44c8-a06e-91ad71c16b01_en?filename=md_new-reg_mir-form-v7.3.1_en.pdf UKFuture Regulation -Implementation: https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulationsConsultation on indefinite recognition of CE marked medical devices and current transitional arrangementsPre-market Statutory Instrument (SI)Future Enhancemens: Exceptional Use Authorization and Health Institution exemptionPost-market Surveillance RequirementsUpdate to guidances Learn Clinical Investigation in the UK - Lot of questions answered: Clinical investigations for electrically powered devices : https://www.gov.uk/government/publications/clinical-investigations-for-electrically-powered-devices/clinical-investigations-for-electrically-powered-devicesClinical investigations: investigators' responsibilities : https://www.gov.uk/government/publications/clinical-investigations-investigators-responsibilities/guidance-for-clincal-investigatorsClinical investigations: statistical considerations : https://www.gov.uk/government/publications/clinical-investigations-statistical-considerations/statistical-considerationsMedical devices that need a clinical investigation: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigationDetermining if Clinical Investigation is required: https://www.gov.uk/government/publications/medical-devices-that-need-a-clinical-investigation/determining-if-a-clinical-investigations-is-requiredClinical Investigation Flow chart: https://assets.publishing.service.gov.uk/media/696f850b5b6060ca6736a0ae/flow_chart_for_clinical_investigations_v3.png EventsTeam NB: Training IVDR -July 2nd 2026: https://www.team-nb.org/wp-content/uploads/2026/03/Leaflet-IVD-TD-Manufacturers-Training-20260702.pdfEgypt: Vigilance reporting Training - April 7 to 9, 2026: https://tinyurl.com/emdpodcastMedtechConf.com - Check the MAPEUSwiss Medtech Day 2026 - June 10, 2026: https://medtechconf.com/event/why-swiss-medtech-day-matters-what-you-should-know/Medtech Forum - May 11, 2026: https://medtechconf.com/event/the-medtech-forum-2026-shaping-the-future-of-medical-technology-in-europe/USVeeva Medtech US Summit- May 11. 2026: https://medtechconf.com/event/veeva-medtech-us-summit-2026-innovation-data-modernization-in-medical-devices/BrazilHospitalar - May 19,2026: https://medtechconf.com/event/hospitalar-the-reference-event-for-healthcare-innovation-and-solutions-in-latin-america/ RoWAustralia: Software Advertisment -What to say: https://www.tga.gov.au/resources/guidance/advertising-software-based-medical-devices-australiaYour advertisement must contain:an accurate description of the devicethe trade name of the devicethe intended purpose(s) of the deviceany mandatory statements and, where relevant, health warnings.For example, you must not:claim your product is “TGA approved”make unsubstantiated claims about the product’s performanceinclude endorsements or testimonials from health professionals or medical researchers.Malaysia: Guidance Creation/Update - Medical Device Act 2012 Guidance on Definition of Medical Devices: https://portal.mda.gov.my/index.php/announcement/1777-publication-of-second-edition-of-guidance-document-on-definition-of-medical-devicesGuidance on confirmation of obsolete and discontinued medical device: https://portal.mda.gov.my/index.php/announcement/1778-publication-of-first-edition-of-guidance-document-on-application-for-confirmation-status-of-obsolete-and-discontinued-medical-devicesGuidance on import and/or supply of unregistered medical devices under special access exemption application: https://portal.mda.gov.my/index.php/announcement/1779-publication-of-third-edition-of-guidance-document-on-import-and-or-supply-of-unregistered-medical-devices-under-special-access-exemption-applicationIndia: FAQ on IVD products - 24 questions with answers: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/Addendum-Doc-No-CDSCOIVDFAQ-042022dated-13032026.pdfEgypt: What you need to register - List of documents: https://tinyurl.com/EmdEgyptRegistration PodcastPodcast Nostalgia -Let's remember: https://podcast.easymedicaldevice.com/Episode 381: EUDAMED deadline 2026: https://podcast.easymedicaldevice.com/381-2/Episode 382: Best-of of 3 podcasts: https://podcast.easymedicaldevice.com/382-2/ ServiceNew Website: https://easymedicaldevice.comAuthorized RepresentativeConsultingTrainingEasyIFU: https://easyifu.comSmarteye: https://eqms-smarteye.com/ This podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
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    28 m
  • These 3 podcasts will change how you see MedTech

    These 3 podcasts will change how you see MedTech
    Mar 26 2026

    The medical device industry is evolving rapidly, driven by stricter regulations, innovation, and global market challenges.
    To help you stay ahead, we’ve gathered the most valuable insights from three MedTech podcasts into one concise summary.

    In this article/video, we explore:

    Key regulatory challenges related to FDA and MDR

    Common mistakes that delay device approval

    Strategic advice from industry experts

    These insights highlight one essential truth: success in MedTech is not only about innovation, but also about understanding regulatory pathways and execution.

    Whether you are a startup founder, regulatory professional, or industry enthusiast, these lessons will help

    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 podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
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    16 m
  • EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare

    EUDAMED Deadline 2026 – 7 Steps Every MedTech Company Must Prepare
    Mar 19 2026

    The upcoming EUDAMED deadline on May 28, 2026, marks a major shift in how regulatory data is managed under the EU MDR and IVDR.

    While many companies believe this transition is simply about uploading documents into a European database, the reality is far more complex.

    EUDAMED is not just a database — it is becoming the central regulatory infrastructure of the European medical device ecosystem, connecting manufacturers, notified bodies, regulators, and economic operators.

    Why EUDAMED Matters

    EUDAMED aims to increase:
    • Transparency
    • Traceability
    • Post-market surveillance
    • Regulatory oversight

    To achieve this, companies must ensure that their internal data is structured, accurate, and aligned with regulatory expectations.

    The Biggest Mistake

    The most common misconception is treating EUDAMED as an IT project.

    In reality, it is a data governance challenge.

    Before uploading any device, companies must clearly define:
    • Device families
    • Basic UDI-DI and UDI-DI
    • Certificate linkage
    • Legal manufacturer responsibilities

    Many organizations struggle with these fundamentals.

    The 7-Step Readiness Checklist

    To prepare effectively, QA/RA teams should focus on:

    Actor registration (SRN)

    Cleaning the device portfolio

    Validating the UDI structure

    Checking certificate data

    Defining legacy device strategy

    Assigning data ownership

    Performing a dry run

    Risks of Delayed Preparation

    Companies that delay preparation may face:
    • Incomplete or inconsistent data
    • Registration delays
    • Regulatory bottlenecks
    • Internal confusion

    EUDAMED could quickly become a regulatory traffic jam for unprepared organizations.

    A Practical Timeline

    To avoid these risks:

    • Immediately: Audit all regulatory data
    • Next 1–2 months: Validate UDI structure and device hierarchy
    • Before the deadline: Perform a full readiness simulation

    Final Takeaway

    EUDAMED is not just a compliance requirement — it is a transformation of how regulatory information is managed in Europe.

    Companies that prepare early will transition smoothly.
    Those that wait may face significant delays and operational challenges.

    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 podcast is powered by Podcastics, the easiest platform to create and publish your podcast.
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    10 m
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