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