Global Medical Device Podcast powered by Greenlight Guru

393 Jaksot

1. Why Design Inputs Are So Important to the Success or Failure of Your Project with Matt Romey

   Julkaistiin: 7.11.2019
2. An Insider’s Look at the Changes Coming in ISO 13485:2016 with Mark Swanson

   Julkaistiin: 7.11.2019
3. Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner

   Julkaistiin: 7.11.2019
4. Medical Device Product Development Project Management Best Practices with Peter Sebelius

   Julkaistiin: 7.11.2019
5. Why the Conventional Wisdom Regarding ‘R’ and ‘D’ in Medtech Product Development Is Wrong

   Julkaistiin: 7.11.2019
6. The Difference Between Intended Use and Indications of Use with Mike Drues

   Julkaistiin: 7.11.2019
7. How to Avoid Medical Device Product Development Wipeouts with Meghan Alonso

   Julkaistiin: 7.11.2019
8. Integrating Business Elements into Your Product Development Process with Therese Graff

   Julkaistiin: 7.11.2019
9. Tips to Help You Prepare for an FDA Inspection

   Julkaistiin: 7.11.2019
10. What Device Makers Need to Know About Design Verification and Validation with Mike Drues

    Julkaistiin: 7.11.2019
11. Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner

    Julkaistiin: 7.11.2019
12. Dirty Devices and Reprocessing: Are New Design Change Rules On the Horizon?

    Julkaistiin: 7.11.2019
13. Insights Into the New FDA 3D Printing Guidance & How It Impacts Med Device New Product Development

    Julkaistiin: 7.11.2019
14. How to Properly Use the FDA Pre-Submission Process and Why It's So Important with Mike Drues

    Julkaistiin: 7.11.2019
15. Insider Tips and Best Practices Regarding the 510(k) Submission Process from a Former FDA Reviewer

    Julkaistiin: 7.11.2019
16. Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

    Julkaistiin: 7.11.2019
17. Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

    Julkaistiin: 7.11.2019
18. Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

    Julkaistiin: 7.11.2019
19. What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

    Julkaistiin: 7.11.2019
20. Understanding the New FDA Guidance on Changes to 510(k)

    Julkaistiin: 7.11.2019