416 Episodo

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

    Publicado: 13/4/2021

  2. 3 Systems of Risk for Medical Devices from FDA

    Publicado: 7/4/2021

  3. Quality Management for IVD Devices vs Medical Devices

    Publicado: 5/4/2021

  4. Understanding the Investigational Device Exemption (IDE) Process

    Publicado: 31/3/2021

  5. Evaluating, Monitoring & Selecting Suppliers in the Medical Device Industry

    Publicado: 30/3/2021

  6. Why the PMA Process is so Dreaded by Manufacturers in the US Market

    Publicado: 25/3/2021

  7. Learning about the Real-world Impact of Design, Manufacturing, Quality & Culture on Patients

    Publicado: 24/3/2021

  8. What is the Safer Technologies Program (STeP) and Can Your Device Use It?

    Publicado: 21/3/2021

  9. Meet a Guru: Sara Adams

    Publicado: 17/3/2021

  10. Building a Startup in the MedTech Industry

    Publicado: 10/3/2021

  11. Meet a Guru: Karen Schuyler

    Publicado: 8/3/2021

  12. Visualizing a Medical Device through Illustrations, Animations, and other Artwork

    Publicado: 4/3/2021

  13. Everything you Need to Know about SaMD from an FDA Perspective

    Publicado: 1/3/2021

  14. Preparing for Remote and On-Site Inspections and Audits

    Publicado: 24/2/2021

  15. How does EU MDR impact your Quality Management System?

    Publicado: 22/2/2021

  16. Virtual Auditing in a Post-COVID World of Digital Compliance

    Publicado: 18/2/2021

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

    Publicado: 10/2/2021

  18. Prioritizing Medical Device Reimbursement During Product Development

    Publicado: 4/2/2021

  19. 5 Actionable Lessons Learned from the RADx Initiative by NIH

    Publicado: 27/1/2021

  20. What are the Strategic Priorities for CDRH in 2021?

    Publicado: 20/1/2021

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