Global Medical Device Podcast powered by Greenlight Guru
Een podcast door Greenlight Guru + Medical Device Entrepreneurs - Maandagen
416 Afleveringen
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How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance
Gepubliceerd: 7-11-2019 -
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Gepubliceerd: 7-11-2019 -
How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster
Gepubliceerd: 7-11-2019 -
How FDA Interacts with Medical Devices When They Are Imported into the US
Gepubliceerd: 7-11-2019 -
Understanding the Connection Between Complaints, CAPAs, and MDRs
Gepubliceerd: 7-11-2019 -
The Intersection of Medical Device Usability and Risk Management
Gepubliceerd: 7-11-2019 -
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device
Gepubliceerd: 7-11-2019 -
Understanding FDA’s Proposed Conformity Assessment Pilot Program
Gepubliceerd: 7-11-2019 -
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device
Gepubliceerd: 7-11-2019 -
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission
Gepubliceerd: 7-11-2019 -
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It
Gepubliceerd: 7-11-2019 -
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy
Gepubliceerd: 7-11-2019 -
Lessons to Be Learned From Recent FDA Inspections
Gepubliceerd: 7-11-2019 -
How Process Excellence Leads to Product Excellence
Gepubliceerd: 7-11-2019 -
Common Mistakes That Can Tank Your FDA 510(k) Submission
Gepubliceerd: 7-11-2019 -
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions
Gepubliceerd: 7-11-2019 -
Challenges with Applying Risk Management Throughout the Manufacturing Process
Gepubliceerd: 7-11-2019 -
An Overview of What Medical Device Developers Need to Know About Human Factors
Gepubliceerd: 7-11-2019 -
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway
Gepubliceerd: 7-11-2019 -
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important
Gepubliceerd: 7-11-2019
The Global Medical Device Podcast, powered by Greenlight Guru, is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
