Medical Device made Easy Podcast

Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2


Listen Later

Podcast Episode 15 – MDR & IVDR discussion with Erik Vollebregt – Part 2

On this new episode, we continue to discuss with Erik Vollebregt on the MDR and IVDR. This is the second part.

If you missed part 1, you should go to:

► https://podcast.easymedicaldevice.com/14/ https://podcast.easymedicaldevice.com/14/

On this part Erik is answering my questions on:

  • New regulation for Small and Big companies
  • Notified bodies reduction
  • Brexit and consequences for Notified Bodies
  • and also rule 11 for classification of software
  • Biography

    Erik specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A. Erik was initially trained as intellectual property and competition lawyer, starting his career at the Directorate-General for Competition of the European Commission. He subsequently gained experience in contentious matters, commercial contracts, and transactional work at three large international law firms.

    He actively contributes to law and policy development at national and EU level via membership of specialized committees at branch associations and the European Commission. Erik also works as arbitrator in medical devices related disputes and is regularly retained as an expert witness in foreign litigation.

    Erik worked and lived in Brussels and Stockholm for several years, and is fluent in Dutch, English, French, German, and Swedish.

    Chambers Europe 2017 about Erik:

    He is known for his specialism in regulatory work, which covers medical technology, devices, and products as well as biotechnology. Clients confirm his strong capabilities, with one saying “he stands out to me. Whenever I work with lawyers he has been the best, with a solid scientific background. He has the perfect combination of skills and experience.”

    References
    • Erik’s Linkedin Profile: https://www.linkedin.com/in/erikvollebregt
  • Erik’s Twitter: https://twitter.com/MedDevLegal
  • Medical Devices Legal Blog: https://medicaldeviceslegal.com/
  • AXON Lawyer: https://www.axonlawyers.com
  • PART 1: https://podcast.easymedicaldevice.com/14/
  • https://www.youtube.com/embed/nL0928StIi0?version=3&rel=1&showsearch=0&showinfo=1&iv_load_policy=1&fs=1&hl=en-US&autohide=2&wmode=transparent

    Youtube Video – MDR & IVDR discussion with Erik Vollebregt – Part 2

    The post Episode 15 – MDR & IVDR discussion with Erik Vollebregt Part 2 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

    7,731 Listeners

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

    The Look & Sound of Leadership

    1,165 Listeners

    Coaching for Leaders by Dave Stachowiak

    Coaching for Leaders

    1,466 Listeners

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

    The Amp Hour Electronics Podcast

    232 Listeners

    This is Money Podcast by This is Money

    This is Money Podcast

    43 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

    657 Listeners

    The Diary Of A CEO with Steven Bartlett by DOAC

    The Diary Of A CEO with Steven Bartlett

    8,854 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

    3,095 Listeners

    The Rest Is Politics: Leading by Goalhanger

    The Rest Is Politics: Leading

    837 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

    2,224 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