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Medtech Matters

En podcast av: Medical Product Outsourcing

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

Our American listeners can also listen to Medtech Matters at our American site

154 Avsnitt

3 Most Common Premarket (Postmarket?) Review Issues FDA Sees
Publicerades 2025-06-25

Why Are One-Third of MAUDE Reports a Problem?
Publicerades 2025-06-10
FDA Guidance on Off-Label Communication, Part 2
Publicerades 2025-05-30
FDA Guidance on Off-Label Communication, Part 1
Publicerades 2025-05-30
Development Considerations for Over-the-Counter Medtech, Part 1
Publicerades 2025-01-23
Development Considerations for OTC Medtech, Part 2
Publicerades 2025-01-23
Device Descriptions in Regulatory Submissions
Publicerades 2025-01-07
Regulatory Ramifications Due to the Presidential Election
Publicerades 2024-11-26
Regulatory Considerations with an Assisted Suicide Machine
Publicerades 2024-11-20
Predetermined Change Control Plans, Part 2
Publicerades 2024-09-24
Predetermined Change Control Plans, Part 1
Publicerades 2024-09-24
What is a CAPA and How Do You Best Use It?
Publicerades 2024-09-03
You Got a 483 from the FDA. Now what?
Publicerades 2024-08-22
Revisiting Real-World Evidence
Publicerades 2024-06-18
The Most Dangerous Devices to Hit the Market
Publicerades 2024-06-11
Headline-Generating Medical Device Safety Concerns
Publicerades 2024-05-02
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
Publicerades 2024-03-19
Examining Institutional Review Boards
Publicerades 2024-03-06
Reimbursing Breakthrough Designation Products
Publicerades 2024-01-02
Strengthening the 510k Program
Publicerades 2023-12-19

A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.

154 Avsnitt

3 Most Common Premarket (Postmarket?) Review Issues FDA Sees

Why Are One-Third of MAUDE Reports a Problem?

FDA Guidance on Off-Label Communication, Part 2

FDA Guidance on Off-Label Communication, Part 1

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

Development Considerations for OTC Medtech, Part 2

Device Descriptions in Regulatory Submissions

Regulatory Ramifications Due to the Presidential Election

Regulatory Considerations with an Assisted Suicide Machine

Predetermined Change Control Plans, Part 2

Predetermined Change Control Plans, Part 1

What is a CAPA and How Do You Best Use It?

You Got a 483 from the FDA. Now what?

Revisiting Real-World Evidence

The Most Dangerous Devices to Hit the Market

Headline-Generating Medical Device Safety Concerns

Analyzing ECRI’s 2024 Top 10 Health Technology Hazards

Examining Institutional Review Boards

Reimbursing Breakthrough Designation Products

Strengthening the 510k Program