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A Preview of MDUFA VI: Changes and Highlights, Part 2	Medtech Matters	51:14
A Preview of MDUFA VI: Changes and Highlights, Part 1	Medtech Matters	49:29
The Value in Partnering for Sterility Testing	Medtech Matters	25:41
ECRI's 2026 Top 10 Health Technology Hazards	Medtech Matters	57:26
Measuring Regulatory/Quality Team Member Performance	Medtech Matters	62:20
FDA's Third-Party Review Program	Medtech Matters	61:00
Triaging Your QMS: Considerations Based on the New QMSR	Medtech Matters	59:19
A Deep Dive into E&L and Biocomp Testing	Medtech Matters	22:09
Planning for FDA Shutdowns Now and in the Future	Medtech Matters	57:28
Should Wellness Products Come with a Warning?	Medtech Matters	66:02
3 Most Common Premarket (Postmarket?) Review Issues FDA Sees	Medtech Matters	53:16
Why Are One-Third of MAUDE Reports a Problem?	Medtech Matters	58:10
FDA Guidance on Off-Label Communication, Part 1	Medtech Matters	51:40
FDA Guidance on Off-Label Communication, Part 2	Medtech Matters	57:13
Development Considerations for Over-the-Counter Medtech, Part 1	Medtech Matters	48:53
Development Considerations for OTC Medtech, Part 2	Medtech Matters	61:16
Device Descriptions in Regulatory Submissions	Medtech Matters	53:06
Regulatory Ramifications Due to the Presidential Election	Medtech Matters	55:17
Regulatory Considerations with an Assisted Suicide Machine	Medtech Matters	52:13
Predetermined Change Control Plans, Part 2	Medtech Matters	59:14
Predetermined Change Control Plans, Part 1	Medtech Matters	50:01
What is a CAPA and How Do You Best Use It?	Medtech Matters	59:45
You Got a 483 from the FDA. Now what?	Medtech Matters	60:15
Revisiting Real-World Evidence	Medtech Matters	55:35
The Most Dangerous Devices to Hit the Market	Medtech Matters	42:14
Headline-Generating Medical Device Safety Concerns	Medtech Matters	50:48
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards	Medtech Matters	53:07
Examining Institutional Review Boards	Medtech Matters	52:43
Reimbursing Breakthrough Designation Products	Medtech Matters	52:50
Strengthening the 510k Program	Medtech Matters	39:38
Medical Device Manufacturing Recalls	Medtech Matters	48:07
AI Predetermined Change Control Plan	Medtech Matters	53:49
Can You Use a Recalled Device as a Predicate?	Medtech Matters	55:12
Leading Issues from FDA Inspections (or History Repeating Itself)	Medtech Matters	47:49
To Regulate or Not to Regulate…LDTs, Part 2	Medtech Matters	50:50
To Regulate or Not to Regulate…Lab Developed Tests, Part 1	Medtech Matters	43:35
What Happens When the EUA Period Ends?	Medtech Matters	49:40
What Does 510k Exempt Actually Mean?	Medtech Matters	52:05
How Can Off-Label Use Be Promoted?	Medtech Matters	50:17
FDA's Intended Use Rule’s Relation to Labeling	Medtech Matters	52:37

A Preview of MDUFA VI: Changes and Highlights, Part 2

Medtech Matters

51:14

A Preview of MDUFA VI: Changes and Highlights, Part 1

Medtech Matters

49:29

The Value in Partnering for Sterility Testing

Medtech Matters

25:41

ECRI's 2026 Top 10 Health Technology Hazards

Medtech Matters

57:26