398 Episoder

  1. 5 Actionable Lessons Learned from the RADx Initiative by NIH

    Publisert: 27.1.2021
  2. What are the Strategic Priorities for CDRH in 2021?

    Publisert: 20.1.2021
  3. Understanding and Handling Different Types of Feedback

    Publisert: 14.1.2021
  4. Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

    Publisert: 7.1.2021
  5. Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

    Publisert: 23.12.2020
  6. Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

    Publisert: 17.12.2020
  7. How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

    Publisert: 9.12.2020
  8. Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

    Publisert: 2.12.2020
  9. What Goes into Designing Devices for Military and Emergency Applications?

    Publisert: 26.11.2020
  10. Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

    Publisert: 19.11.2020
  11. Positive and Negative Impacts of EUA on the Medical Device Industry

    Publisert: 12.11.2020
  12. Why Biocompatibility Should be Addressed by Every Medical Device Company

    Publisert: 4.11.2020
  13. Meet a Guru: Erica Loring

    Publisert: 28.10.2020
  14. What is a Multiple Function Device?

    Publisert: 30.9.2020
  15. Challenges related to Home Use Devices

    Publisert: 10.9.2020
  16. Submitting a 510(k) using FDA's Safety and Performance Based Pathway

    Publisert: 2.9.2020
  17. How Jon Speer Met His Most Frequent Guest: Mike Drues

    Publisert: 26.8.2020
  18. Meet a Guru: Wade Schroeder

    Publisert: 20.8.2020
  19. What are the Audit Etiquette Rules I Should be Following?

    Publisert: 12.8.2020
  20. Meet a Guru: Tom Rish

    Publisert: 5.8.2020

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