Global Medical Device Podcast powered by Greenlight Guru

416 Episodes

1. How to Choose the Right FDA Regulatory Pathway for your Device

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

   Published: 2/19/2020
3. 4 Parts to Interviewing Candidates for Medical Device Roles

   Published: 2/13/2020
4. 5 Tips for Hiring Medical Device Advisors

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

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

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

   Published: 12/19/2019
8. 5 Myths about QA/RA Recruiting in the Medical Device Industry

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

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

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

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

    Published: 11/26/2019
13. Helping Prepare Biomedical Engineers Entering the Workforce

    Published: 11/7/2019
14. Tips, Tricks & Best Practices for Complying with ISO 13485:2016

    Published: 11/7/2019
15. How to Ensure Your Quality Management System is Effective and Benefits Patients

    Published: 11/7/2019
16. How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

    Published: 11/7/2019
17. FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

    Published: 11/7/2019
18. How to Design for Compliance with IEC 60601

    Published: 11/7/2019
19. How to Think About Quality and Regulatory as Your Company Scales

    Published: 11/7/2019
20. What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

    Published: 11/7/2019