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Why Are One-Third of MAUDE Reports a Problem?	Medtech Matters	56:38
FDA Guidance on Off-Label Communication, Part 1	Medtech Matters	50:08
FDA Guidance on Off-Label Communication, Part 2	Medtech Matters	55:41
Development Considerations for Over-the-Counter Medtech, Part 1	Medtech Matters	47:21
Development Considerations for OTC Medtech, Part 2	Medtech Matters	59:44
Device Descriptions in Regulatory Submissions	Medtech Matters	51:34
Regulatory Ramifications Due to the Presidential Election	Medtech Matters	53:45
Regulatory Considerations with an Assisted Suicide Machine	Medtech Matters	50:41
Predetermined Change Control Plans, Part 2	Medtech Matters	57:41
Predetermined Change Control Plans, Part 1	Medtech Matters	48:29
What is a CAPA and How Do You Best Use It?	Medtech Matters	58:13
You Got a 483 from the FDA. Now what?	Medtech Matters	58:43
Revisiting Real-World Evidence	Medtech Matters	54:03
The Most Dangerous Devices to Hit the Market	Medtech Matters	40:42
Headline-Generating Medical Device Safety Concerns	Medtech Matters	49:16
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards	Medtech Matters	51:35
Examining Institutional Review Boards	Medtech Matters	51:11
Reimbursing Breakthrough Designation Products	Medtech Matters	51:18
Strengthening the 510k Program	Medtech Matters	38:06
Medical Device Manufacturing Recalls	Medtech Matters	46:35
AI Predetermined Change Control Plan	Medtech Matters	52:17
Can You Use a Recalled Device as a Predicate?	Medtech Matters	53:40
Leading Issues from FDA Inspections (or History Repeating Itself)	Medtech Matters	46:17
To Regulate or Not to Regulate…LDTs, Part 2	Medtech Matters	49:18
To Regulate or Not to Regulate…Lab Developed Tests, Part 1	Medtech Matters	42:03
What Happens When the EUA Period Ends?	Medtech Matters	48:08
What Does 510k Exempt Actually Mean?	Medtech Matters	50:33
How Can Off-Label Use Be Promoted?	Medtech Matters	48:46
FDA's Intended Use Rule’s Relation to Labeling	Medtech Matters	51:05
Gaining an Advantage Through Class II Special Controls	Medtech Matters	47:15
FDA’s Refuse to Accept Policy for 510(k)s	Medtech Matters	50:36
Initiating a Voluntary Medical Device Recall	Medtech Matters	47:21
A Letter to File Deep Dive	Medtech Matters	45:24
Humacyte’s Bioengineered Tissue Platform Technology	Medtech Matters	27:37
Koya Medical Restores Mobility for Compression Therapy Patients	Medtech Matters	26:58
NeuroPace’s Aid in Tracking and Treating Epilepsy	Medtech Matters	20:00
Aidoc Is Improving Patient Outcomes Through AI	Medtech Matters	21:25
Performing a Gap Analysis on FDA's Regulatory Protocols	Medtech Matters	43:38
Stereotaxis’ Robotic Surgery System for Interventional Procedures	Medtech Matters	22:46
Fighting Tumors with Varian’s FLASH Technology	Medtech Matters	23:14

Why Are One-Third of MAUDE Reports a Problem?

Medtech Matters

56:38

FDA Guidance on Off-Label Communication, Part 1

Medtech Matters

50:08

FDA Guidance on Off-Label Communication, Part 2

Medtech Matters

55:41

Development Considerations for Over-the-Counter Medtech, Part 1

Medtech Matters

47:21