Global Medical Device Podcast powered by Greenlight Guru

398 Episoder

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

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

   Publisert: 7.11.2019
3. Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

   Publisert: 7.11.2019
4. Zebra Medical Technologies: How a New Breed of Medical Device Companies Is Leveraging Technology

   Publisert: 7.11.2019
5. Understanding the New FDA Guidance on Changes to 510(k)

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

   Publisert: 7.11.2019
7. Using the Bucket Method for Medical Device Risk Management w/ Mike Drues

   Publisert: 7.11.2019
8. Tips for Success When It Comes to IEC 60601 with Leo Eisner

   Publisert: 7.11.2019
9. 2016 Medical Device Regulatory Trends Year in Review

   Publisert: 7.11.2019
10. How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance

    Publisert: 7.11.2019
11. Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?

    Publisert: 7.11.2019
12. What Devicemakers Need to Know About Medical Device Reporting (MDR)

    Publisert: 7.11.2019
13. An Overview of What Device Makers Need to Know About CAPA

    Publisert: 7.11.2019
14. How Phagenesis Is Using Regulatory Affairs as They Develop a Treatment for Dysphagia

    Publisert: 7.11.2019
15. How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster

    Publisert: 7.11.2019
16. How FDA Interacts with Medical Devices When They Are Imported into the US

    Publisert: 7.11.2019
17. Understanding the Connection Between Complaints, CAPAs, and MDRs

    Publisert: 7.11.2019
18. The Intersection of Medical Device Usability and Risk Management

    Publisert: 7.11.2019
19. When Design Inputs Go Wrong + Design Your Label Like You Design Your Device

    Publisert: 7.11.2019
20. Understanding FDA’s Proposed Conformity Assessment Pilot Program

    Publisert: 7.11.2019