Global Medical Device Podcast powered by Greenlight Guru

398 Episodes

1. Sara Naab On Going From Idea to Funding to One of the Bay Area's Most Innovative Life Sciences Co's

   Published: 11/7/2019
2. Tips, Tricks and Pointers for MedTech Startup Entrepreneurs With Mitch Levinson

   Published: 11/7/2019
3. How To Avoid Major Common Mistakes During the 510(k) Process with Michael Drues

   Published: 11/7/2019
4. How To Identify, Quantify & Manage Enterprise Risks for Medical Device Companies with Mike Cremeans

   Published: 11/7/2019
5. Why Medical Device Startups Need to Implement a ‘Right-Sized’ QMS with David Amor

   Published: 11/7/2019
6. Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

   Published: 11/7/2019
7. Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

   Published: 11/7/2019
8. An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

   Published: 11/7/2019
9. Medical Device Product Development Project Management Best Practices with Peter Sebelius

   Published: 11/7/2019
10. Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

    Published: 11/7/2019
11. The Difference Between Intended Use and Indications of Use with Mike Drues

    Published: 11/7/2019
12. How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

    Published: 11/7/2019
13. Integrating Business Elements into Your Product Development Process with Therese Graff

    Published: 11/7/2019
14. Tips to Help You Prepare for an FDA Inspection

    Published: 11/7/2019
15. What Device Makers Need to Know About Design Verification and Validation with Mike Drues

    Published: 11/7/2019
16. Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

    Published: 11/7/2019
17. Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

    Published: 11/7/2019
18. Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

    Published: 11/7/2019
19. Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

    Published: 11/7/2019
20. How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

    Published: 11/7/2019