Global Medical Device Podcast powered by Greenlight Guru

398 Folgen

1. Understanding the Difference Between a General Wellness Device and a Regulated Medical Device

   Vom: 7.11.2019
2. Why the 510(k) Process Is So Stressful & How You Can Help Streamline It

   Vom: 7.11.2019
3. How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy

   Vom: 7.11.2019
4. How Process Excellence Leads to Product Excellence

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

   Vom: 7.11.2019
6. Lessons to Be Learned From Recent FDA Inspections

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

   Vom: 7.11.2019
8. Common Mistakes That Can Tank Your FDA 510(k) Submission

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

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10. Challenges with Applying Risk Management Throughout the Manufacturing Process

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

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

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13. 5 Most Common Problems With Your CAPA Process

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14. How to Determine the Operational Quality of a Quality System Using a Performance Assessment

    Vom: 7.11.2019
15. Tips, Tricks & Best Practices for Complying with ISO 13485:2016

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16. Helping Prepare Biomedical Engineers Entering the Workforce

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17. How to Ensure Your Quality Management System is Effective and Benefits Patients

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18. Debunking Premarket Approval (PMA) Myths (And Why the PMA Path May Not Be as Scary as You Think)

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19. How to Think About Quality and Regulatory as Your Company Scales

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

    Vom: 7.11.2019