Global Medical Device Podcast powered by Greenlight Guru
A podcast by Greenlight Guru + Medical Device Entrepreneurs - Lunedì
416 Episodio
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How Surgical Innovation Associates Found the Benefit of Quality Beyond Just Compliance
Pubblicato: 07/11/2019 -
Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?
Pubblicato: 07/11/2019 -
How SimplicityMD Is Leveraging Technology to Help Get Their Devices to Market Faster
Pubblicato: 07/11/2019 -
How FDA Interacts with Medical Devices When They Are Imported into the US
Pubblicato: 07/11/2019 -
Understanding the Connection Between Complaints, CAPAs, and MDRs
Pubblicato: 07/11/2019 -
The Intersection of Medical Device Usability and Risk Management
Pubblicato: 07/11/2019 -
When Design Inputs Go Wrong + Design Your Label Like You Design Your Device
Pubblicato: 07/11/2019 -
Understanding FDA’s Proposed Conformity Assessment Pilot Program
Pubblicato: 07/11/2019 -
Understanding the Difference Between a General Wellness Device and a Regulated Medical Device
Pubblicato: 07/11/2019 -
Comparing FDA Submission Types: 510(k) vs. De Novo vs. 513(g) vs. Pre-Submission
Pubblicato: 07/11/2019 -
Why the 510(k) Process Is So Stressful & How You Can Help Streamline It
Pubblicato: 07/11/2019 -
How Competitive Regulatory Strategy Differs from Regular Regulatory Strategy
Pubblicato: 07/11/2019 -
Lessons to Be Learned From Recent FDA Inspections
Pubblicato: 07/11/2019 -
How Process Excellence Leads to Product Excellence
Pubblicato: 07/11/2019 -
Common Mistakes That Can Tank Your FDA 510(k) Submission
Pubblicato: 07/11/2019 -
Understanding How to Use Real-World Evidence for Medical Device Regulatory Decisions
Pubblicato: 07/11/2019 -
Challenges with Applying Risk Management Throughout the Manufacturing Process
Pubblicato: 07/11/2019 -
An Overview of What Medical Device Developers Need to Know About Human Factors
Pubblicato: 07/11/2019 -
Evaluating FDA’s “New” Proposed Fast-Track Alternative Approach to the 510(k) Pathway
Pubblicato: 07/11/2019 -
What Substantial Equivalence Means as It Applies to 510(k)'s & Why It's So Important
Pubblicato: 07/11/2019
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.
