Global Medical Device Podcast powered by Greenlight Guru

416 Episoder

1. Integrating Business Elements into Your Product Development Process with Therese Graff

   Udgivet: 7.11.2019
2. Tips to Help You Prepare for an FDA Inspection

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

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

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

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

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

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

   Udgivet: 7.11.2019
9. Tips & Pointers for Effective Internal Quality Audits with Kyle Rose

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

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

    Udgivet: 7.11.2019
12. Understanding the New FDA Guidance on Changes to 510(k)

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

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

    Udgivet: 7.11.2019
15. Tips for Success When It Comes to IEC 60601 with Leo Eisner

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

    Udgivet: 7.11.2019
17. 2016 Medical Device Regulatory Trends Year in Review

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

    Udgivet: 7.11.2019
19. What Devicemakers Need to Know About Medical Device Reporting (MDR)

    Udgivet: 7.11.2019
20. An Overview of What Device Makers Need to Know About CAPA

    Udgivet: 7.11.2019