Global Medical Device Podcast powered by Greenlight Guru

393 Jaksot

1. Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission

   Julkaistiin: 7.11.2019
2. Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions

   Julkaistiin: 7.11.2019
3. Common Mistakes That Can Tank Your FDA 510(k) Submission

   Julkaistiin: 7.11.2019
4. Challenges with Applying Risk Management Throughout the Manufacturing Process

   Julkaistiin: 7.11.2019
5. An Overview of What Medical Device Developers Need to Know About Human Factors

   Julkaistiin: 7.11.2019
6. Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway

   Julkaistiin: 7.11.2019
7. What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important

   Julkaistiin: 7.11.2019
8. How to Determine the Operational Quality of a Quality System Using a Performance Assessment

   Julkaistiin: 7.11.2019
9. 5 Most Common Problems With Your CAPA Process

   Julkaistiin: 7.11.2019
10. How to Ensure Your Quality Management System is Effective and Benefits Patients

    Julkaistiin: 7.11.2019
11. Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

    Julkaistiin: 7.11.2019
12. Helping Prepare Biomedical Engineers Entering the Workforce

    Julkaistiin: 7.11.2019
13. Tips, Tricks & Best Practices for Complying with ISO 13485:2016

    Julkaistiin: 7.11.2019
14. How to Use the Abbreviated FDA 510(k) Pathway to Your Advantage

    Julkaistiin: 7.11.2019
15. How to Design for Compliance with IEC 60601

    Julkaistiin: 7.11.2019
16. FDA Proposes Allowing Medical Device Makers to Summarize Malfunctions: What does that Mean for You?

    Julkaistiin: 7.11.2019
17. How to Think About Quality and Regulatory as Your Company Scales

    Julkaistiin: 7.11.2019
18. How Human Factors Impact Your Medical Device

    Julkaistiin: 7.11.2019
19. What you Need to Know about FDA's Progressive Programs

    Julkaistiin: 7.11.2019
20. What are the Regulatory Expectations for Software as a Medical Device (SaMD)?

    Julkaistiin: 7.11.2019