ECRI's 2026 Top 10 Health Technology Hazards
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re reviewing the list of top...
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Medtech Matters
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
Episodes
20 of 160 episodesMeasuring Regulatory/Quality Team Member Performance
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re speaking about how to best...
FDA's Third-Party Review Program
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s third...
Triaging Your QMS: Considerations Based on the New QMSR
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re discussing the FDA’s recen...
A Deep Dive into E&L and Biocomp Testing
In this Medtech Matters podcast episode, sponsored by Nelson Labs , we’re discussing the importance of E&L (extractables and leachables) and...
Planning for FDA Shutdowns Now and in the Future
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing the government...
Should Wellness Products Come with a Warning?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re speaking about a recent E...
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re highlighting comments mad...
Why Are One-Third of MAUDE Reports a Problem?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing MAUDE safety r...
FDA Guidance on Off-Label Communication, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re speaking about off-label...
FDA Guidance on Off-Label Communication, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re continuing our conversati...
Development Considerations for Over-the-Counter Medtech, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing over-the-count...
Development Considerations for OTC Medtech, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re continuing our conversati...
Device Descriptions in Regulatory Submissions
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing a common part...
Regulatory Ramifications Due to the Presidential Election
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re looking at the potential...
Regulatory Considerations with an Assisted Suicide Machine
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re drawing inspiration from...
Predetermined Change Control Plans, Part 2
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we continue speaking on the top...
Predetermined Change Control Plans, Part 1
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we examine the FDA’s recent gui...
What is a CAPA and How Do You Best Use It?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re focusing in on a regulato...
You Got a 483 from the FDA. Now what?
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences , we’re discussing what the proce...