Global Medical Device Podcast powered by Greenlight Guru

398 Episodes

1. How to Leverage IEC 62304 to Improve SaMD Development Processes

   Published: 3/18/2020
2. What is the eSTAR Pilot Program and How Will it Improve FDA's 510(k) Review Process?

   Published: 3/12/2020
3. How to Choose the Right FDA Regulatory Pathway for your Device

   Published: 2/26/2020
4. How to Establish a Solid Foundation for Fundraising and Product Success by Focusing on Regulatory

   Published: 2/19/2020
5. 4 Parts to Interviewing Candidates for Medical Device Roles

   Published: 2/13/2020
6. 5 Tips for Hiring Medical Device Advisors

   Published: 2/5/2020
7. 2 Key Areas Missing from FDA CDRH's Regulatory Science Priorities for 2020

   Published: 1/29/2020
8. Navigating the Twists and Turns of Change Management for Medical Devices

   Published: 12/28/2019
9. What is FDA's ASCA Pilot Program and How Does it Impact Medical Device Manufacturers?

   Published: 12/19/2019
10. 5 Myths about QA/RA Recruiting in the Medical Device Industry

    Published: 12/11/2019
11. How to Solve the Medtech Value Equation with Quality Data

    Published: 12/5/2019
12. Why Supplier Quality Management Is So Important For Medical Device Companies

    Published: 11/27/2019
13. Preparing for EU MDR

    Published: 11/26/2019
14. FDA is Expanding its Case for Quality Program... Should Your Company Participate?

    Published: 11/26/2019
15. Best Practices for Implementing Design Controls for the Medical Device Industry

    Published: 11/7/2019
16. Should design controls have prevented the recent reprocessing tragedy: Do we need new regulation?

    Published: 11/7/2019
17. How to Improve Your Medical Device Design Reviews Bonus Episode

    Published: 11/7/2019
18. How To Improve Your Medical Device Design Reviews

    Published: 11/7/2019
19. Risk Management from a Regulatory & Product Development Point of View

    Published: 11/7/2019
20. How Proper Design Controls & a Quality System Could Save You $20M With Ronny Bracken

    Published: 11/7/2019