Global Medical Device Podcast powered by Greenlight Guru

398 Episodes

1. Mastering Device Descriptions: The Cornerstone of Medical Device Submissions

   Published: 12/19/2024
2. #395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

   Published: 12/12/2024
3. #394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

   Published: 12/6/2024
4. #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

   Published: 11/29/2024
5. #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

   Published: 11/22/2024
6. #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

   Published: 11/14/2024
7. #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

   Published: 11/7/2024
8. #389: Pre-determined Change Control Plans

   Published: 10/31/2024
9. #388: Elements of an Effective CAPA Program

   Published: 10/24/2024
10. #387: The case for Real World Evidence Studies

    Published: 10/17/2024
11. #386: The Danger of In-Home Use Medical Devices, Pt. 2

    Published: 10/10/2024
12. #385: The Trouble with Home-Use Devices, Pt. 1

    Published: 10/4/2024
13. #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

    Published: 9/26/2024
14. #383: What Standards Apply to My Device?

    Published: 9/19/2024
15. #382: Design of Experiments - How and When to Use DOE

    Published: 9/12/2024
16. #381: MedTech Advice from an Accidental Entrepreneur

    Published: 9/5/2024
17. #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Published: 8/30/2024
18. #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

    Published: 8/15/2024
19. #378: Who Owns the Design Controls Process?

    Published: 8/8/2024
20. #377: Designing a Medical Device for a Global User

    Published: 7/25/2024