Hallgasd meg ezt a podcastot: Medtech Matters

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	59:13
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	42:13
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
Gaining an Advantage Through Class II Special Controls	Medtech Matters	48:47
FDA’s Refuse to Accept Policy for 510(k)s	Medtech Matters	52:07
Initiating a Voluntary Medical Device Recall	Medtech Matters	48:53
A Letter to File Deep Dive	Medtech Matters	46:56
Humacyte’s Bioengineered Tissue Platform Technology	Medtech Matters	29:09
Koya Medical Restores Mobility for Compression Therapy Patients	Medtech Matters	28:30
NeuroPace’s Aid in Tracking and Treating Epilepsy	Medtech Matters	20:50
Aidoc Is Improving Patient Outcomes Through AI	Medtech Matters	22:15

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