416 Épisodes

  1. Pros & Cons of Being a Physician turned MedTech Inventor

    Publié: 13/04/2021
  2. 3 Systems of Risk for Medical Devices from FDA

    Publié: 07/04/2021
  3. Quality Management for IVD Devices vs Medical Devices

    Publié: 05/04/2021
  4. Understanding the Investigational Device Exemption (IDE) Process

    Publié: 31/03/2021
  5. Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

    Publié: 30/03/2021
  6. Why the PMA Process is so Dreaded by Manufacturers in the US Market

    Publié: 25/03/2021
  7. Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

    Publié: 24/03/2021
  8. What is the Safer Technologies Program (STeP) and Can Your Device Use It?

    Publié: 21/03/2021
  9. Meet a Guru: Sara Adams

    Publié: 17/03/2021
  10. Building a Startup in the MedTech Industry

    Publié: 10/03/2021
  11. Meet a Guru: Karen Schuyler

    Publié: 08/03/2021
  12. Visualizing a Medical Device through Illustrations, Animations, and other Artwork

    Publié: 04/03/2021
  13. Everything you Need to Know about SaMD from an FDA Perspective

    Publié: 01/03/2021
  14. Preparing for Remote and On-Site Inspections and Audits

    Publié: 24/02/2021
  15. How does EU MDR impact your Quality Management System?

    Publié: 22/02/2021
  16. Virtual Auditing in a Post-COVID World of Digital Compliance

    Publié: 18/02/2021
  17. Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

    Publié: 10/02/2021
  18. Prioritizing Medical Device Reimbursement During Product Development

    Publié: 04/02/2021
  19. 5 Actionable Lessons Learned from the RADx Initiative by NIH

    Publié: 27/01/2021
  20. What are the Strategic Priorities for CDRH in 2021?

    Publié: 20/01/2021

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