Global Medical Device Podcast powered by Greenlight Guru

398 Folgen

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

   Vom: 19.12.2024
2. #395: IEC 60601 Updates: What MedTech Professionals Need to Know for 2025 and Beyond

   Vom: 12.12.2024
3. #394: Class III PMAs in MedTech: Advantages, Misconceptions, and Competitive Strategies with Dr. Mike Drues

   Vom: 6.12.2024
4. #393: Engineering MedTech Success: Simplifying Prototypes, Pivoting Strategy, and Creating Complex Designs with Justin Bushko

   Vom: 29.11.2024
5. #392: Verification and Validation in MedTech: A Practical Guide with Devon Campbell

   Vom: 22.11.2024
6. #391: Creating a Regulatory Roadmap for MedTech Market Success with Adnan Ashfaq

   Vom: 14.11.2024
7. #390: Building a Non-BS QMS: 4 Core Principles for MedTech Success with Ashkon Rasooli

   Vom: 7.11.2024
8. #389: Pre-determined Change Control Plans

   Vom: 31.10.2024
9. #388: Elements of an Effective CAPA Program

   Vom: 24.10.2024
10. #387: The case for Real World Evidence Studies

    Vom: 17.10.2024
11. #386: The Danger of In-Home Use Medical Devices, Pt. 2

    Vom: 10.10.2024
12. #385: The Trouble with Home-Use Devices, Pt. 1

    Vom: 4.10.2024
13. #384: Insights from an Ex-FDA Investigator: Compliance, Quality Systems, and MedTech Trends

    Vom: 26.9.2024
14. #383: What Standards Apply to My Device?

    Vom: 19.9.2024
15. #382: Design of Experiments - How and When to Use DOE

    Vom: 12.9.2024
16. #381: MedTech Advice from an Accidental Entrepreneur

    Vom: 5.9.2024
17. #380: Navigating the Complex World of Combination Products with Subhi Saadeh

    Vom: 30.8.2024
18. #379: Meet the Guru - Building Quality Management in Early-Stage Medical Device Companies and other Insights from a Veteran Engineer

    Vom: 15.8.2024
19. #378: Who Owns the Design Controls Process?

    Vom: 8.8.2024
20. #377: Designing a Medical Device for a Global User

    Vom: 25.7.2024