Global Medical Device Podcast powered by Greenlight Guru

398 Episodes

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

   Published: 1/27/2021
2. What are the Strategic Priorities for CDRH in 2021?

   Published: 1/20/2021
3. Understanding and Handling Different Types of Feedback

   Published: 1/14/2021
4. Measuring the Impact of AI/ML Technologies on the Current Medical Device Landscape

   Published: 1/7/2021
5. Post-Pandemic Readiness: Preparing for the Aftermath of COVID-19 on the Medical Device Industry

   Published: 12/23/2020
6. Tips to Prepare for EU MDR and IVDR as Deadlines Draw Near

   Published: 12/17/2020
7. How will Emergency Use Authorization (EUA) during Pandemic Influence Future FDA Policy Changes?

   Published: 12/9/2020
8. Why SaMD Companies Should be Leveraging Pre-Submissions to FDA

   Published: 12/2/2020
9. What Goes into Designing Devices for Military and Emergency Applications?

   Published: 11/26/2020
10. Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

    Published: 11/19/2020
11. Positive and Negative Impacts of EUA on the Medical Device Industry

    Published: 11/12/2020
12. Why Biocompatibility Should be Addressed by Every Medical Device Company

    Published: 11/4/2020
13. Meet a Guru: Erica Loring

    Published: 10/28/2020
14. What is a Multiple Function Device?

    Published: 9/30/2020
15. Challenges related to Home Use Devices

    Published: 9/10/2020
16. Submitting a 510(k) using FDA's Safety and Performance Based Pathway

    Published: 9/2/2020
17. How Jon Speer Met His Most Frequent Guest: Mike Drues

    Published: 8/26/2020
18. Meet a Guru: Wade Schroeder

    Published: 8/20/2020
19. What are the Audit Etiquette Rules I Should be Following?

    Published: 8/12/2020
20. Meet a Guru: Tom Rish

    Published: 8/5/2020