Global Medical Device Podcast powered by Greenlight Guru

368 Episodes

1. #346: FDAs eSTAR Program

   Published: 11/30/2023
2. #345: Using AI In MedTech

   Published: 11/22/2023
3. #344: Becoming an Advisor to a Medical Device Company

   Published: 11/16/2023
4. #343: Recent FDA Draft Guidances

   Published: 11/9/2023
5. #342: Planning an FDA Submission

   Published: 11/2/2023
6. #341: What NOT to say to FDA

   Published: 10/25/2023
7. #340: LDTs & the FDAs Proposed Ruling

   Published: 10/19/2023
8. #339: UDI and the State of EUDAMED

   Published: 10/12/2023
9. #338: Site Selection for Clinical Trials

   Published: 10/6/2023
10. #337: Moving MedTech Forward - The Past, Present & Future of Greenlight Guru

    Published: 9/21/2023
11. #336: From Academia to FDA Clearance (True Quality Roadshow - Boston)

    Published: 9/14/2023
12. #335: Accelerating SaMD Development in a Compliant Agile way

    Published: 9/8/2023
13. #334: MedTech Funding and Preparing for Due Diligence

    Published: 8/31/2023
14. #333: Exploring Breakthrough Device Designation

    Published: 8/25/2023
15. #332: Regulatory Strategy and the Advantage of Diversity in MedTech

    Published: 8/17/2023
16. #331: 28 Days To Save The World: Lessons Learned from a Pandemic Month of Supply Chain Issues

    Published: 8/10/2023
17. #330: 3P510k: What Is a 510k 3rd Party Review, and What are the Benefits?

    Published: 8/3/2023
18. #329 The Right Way to Start a QMS: When, How, & What

    Published: 7/27/2023
19. #328 FDA Guidance on Artificial Intelligence (AI) in Medical Devices

    Published: 7/20/2023
20. #327 Understanding the ROI of an eQMS

    Published: 7/11/2023