Global Medical Device Podcast powered by Greenlight Guru

398 Episodes

1. Tips for Avoiding Problems with the First-In-Human Study Process with Mike Drues

   Published: 11/7/2019
2. Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

   Published: 11/7/2019
3. Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

   Published: 11/7/2019
4. Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

   Published: 11/7/2019
5. Understanding the New FDA Guidance on Changes to 510(k)

   Published: 11/7/2019
6. What Devicemakers Need to Know about the FDA Pre-submission Process (Part Two)

   Published: 11/7/2019
7. Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

   Published: 11/7/2019
8. Tips for Success When It Comes to IEC 60601 with Leo Eisner

   Published: 11/7/2019
9. 2016 Medical Device Regulatory Trends Year in Review

   Published: 11/7/2019
10. How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

    Published: 11/7/2019
11. Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

    Published: 11/7/2019
12. What Devicemakers Need to Know About Medical Device Reporting (MDR)

    Published: 11/7/2019
13. An Overview of What Device Makers Need to Know About CAPA

    Published: 11/7/2019
14. How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

    Published: 11/7/2019
15. How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

    Published: 11/7/2019
16. How FDA Interacts with Medical Devices When They Are Imported into the US

    Published: 11/7/2019
17. Understanding the Connection Between Complaints, CAPAs, and MDRs

    Published: 11/7/2019
18. The Intersection of Medical Device Usability and Risk Management

    Published: 11/7/2019
19. When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

    Published: 11/7/2019
20. Understanding FDA’s Proposed Conformity Assessment Pilot Program

    Published: 11/7/2019