Global Medical Device Podcast powered by Greenlight Guru

398 Episoder

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

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

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

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

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

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

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

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

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

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

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

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

    Udgivet: 4.11.2020
13. Meet a Guru: Erica Loring

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

    Udgivet: 30.9.2020
15. Challenges related to Home Use Devices

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

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

    Udgivet: 26.8.2020
18. Meet a Guru: Wade Schroeder

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

    Udgivet: 12.8.2020
20. Meet a Guru: Tom Rish

    Udgivet: 5.8.2020