Medical Device made Easy Podcast

Medical Device News – August 2020 Review (Monir El Azzouzi)

Listen Later

https://www.youtube.com/embed/bTdE2Wrlzts?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

The Medical Device industry is still moving a few steps forward to EU MDR 2017/745. Here is the agenda of this review:

  • UDI
  • Cardiac Implantable Electronic Devices (CIED)
  • Rolling plan (EUDAMED + Reprocessing of single-use devices)
  • Green Belt Certificate (New session in French)
  • Notified Body Situation
  • New guidance and Standards
  • Review of the podcast episodes

    • In this version, the VIDEO PARODY CLIP was blurred as there are some copyrights to the USA.

    Who is Monir El Azzouzi?

    Monir El Azzouzi is a Medical Device Expert specialized in Quality and Regulatory Affairs. After working for many years with big Healthcare company and particularly Johnson and Johnson, he decided to create EasyMedicalDevice.com to help people have a better understanding of the Medical Device Regulations all over the world.

    He now created the consulting firm Easy Medical Device GmbH and developed many ways to deliver knowledge through Videos, Podcast, Online courses…

    Links Hot Topics
    • UDI FAQ: https://ec.europa.eu/docsroom/documents/42641?locale=en
  • CIED guidance: https://ec.europa.eu/docsroom/documents/37283
  • Rolling Plan of August: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_rolling-plan_en.xlsx
  • Regulation 2020/1207 Reprocessing of single-use devices: https://eur-lex.europa.eu/eli/reg_impl/2020/1207/oj
  • Green Belt Certificate: https://school.easymedicaldevice.com
    • Notified Bodies
    • DQS MED notified Body: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notification.html&ntf_id=308392&version_no=9
    New Guidance and Standards
    • ISO 14155:2020 Clinical Investigation: https://www.iso.org/standard/71690.html
  • LinkedIn Post Helene Quie: https://www.linkedin.com/pulse/revision-iso-14155-available-helene-quie/
  • MDCG 2020-14 – MDSAP report: https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_2020-14-guidance-mdsap_en.pdf
  • MDCG 2020-15 – Eudamed Actor Module: https://ec.europa.eu/health/sites/health/files/md_sector/docs/2020-15-position-paper-actor-registration-module_en.pdf
    • Podcast
    • Episode 88 – IEC 60601 with Leo Eisner https://podcast.easymedicaldevice.com/88
  • Episode 89 – Medical Device Testing with Michael Wetherington https://podcast.easymedicaldevice.com/89
  • Episode 90 – Virtual Conferences with TOPRA https://podcast.easymedicaldevice.com/90
  • TOPRA symposium: https://www.topra.org/sym2019

    • The post Medical Device News – August 2020 Review (Monir El Azzouzi) appeared first on Medical Device made Easy Podcast. Monir El Azzouzi

    ...more
    View all episodesView all episodes
    Download on the App Store
    Medical Device made Easy PodcastBy easymedicaldevice
    • 4.8
    • 4.8
    • 4.8
    • 4.8
    • 4.8

    4.8

    20 ratings

    More shows like Medical Device made Easy Podcast

    View all
    Global News Podcast by BBC World Service

    Global News Podcast

    7,728 Listeners

    The Look & Sound of Leadership by Essential Communications - Tom Henschel

    The Look & Sound of Leadership

    1,164 Listeners

    Coaching for Leaders by Dave Stachowiak

    Coaching for Leaders

    1,468 Listeners

    The Amp Hour Electronics Podcast by The Amp Hour (Chris Gammell and David L Jones)

    The Amp Hour Electronics Podcast

    231 Listeners

    This is Money Podcast by This is Money

    This is Money Podcast

    44 Listeners

    Global Medical Device Podcast powered by Greenlight Guru by Greenlight Guru + Medical Device Entrepreneurs

    Global Medical Device Podcast powered by Greenlight Guru

    93 Listeners

    Newscast by BBC News

    Newscast

    652 Listeners

    The Diary Of A CEO with Steven Bartlett by DOAC

    The Diary Of A CEO with Steven Bartlett

    8,830 Listeners

    Handelsblatt Disrupt - Der Podcast über die Zukunft der Wirtschaft by Sebastian Matthes, Handelsblatt

    Handelsblatt Disrupt - Der Podcast über die Zukunft der Wirtschaft

    19 Listeners

    The Rest Is Politics by Goalhanger

    The Rest Is Politics

    3,103 Listeners

    The Rest Is Politics: Leading by Goalhanger

    The Rest Is Politics: Leading

    829 Listeners

    HBR On Leadership by Harvard Business Review

    HBR On Leadership

    158 Listeners

    Leben mit Aktien | Der Podcast für Anleger mit Weitblick by Horst von Buttlar, Christian W. Röhl

    Leben mit Aktien | Der Podcast für Anleger mit Weitblick

    2 Listeners

    The Rest Is Politics: US by Goalhanger

    The Rest Is Politics: US

    2,228 Listeners

    Let's Talk Risk! with Dr. Naveen Agarwal by Casual and informal conversations about practical aspects of medical device risk management.

    Let's Talk Risk! with Dr. Naveen Agarwal

    2 Listeners