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