Medtech Matters
A podcast by Medical Product Outsourcing - Tuesdays
Categories:
143 Episodes
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What is a CAPA and How Do You Best Use It?
Published: 9/3/2024 -
You Got a 483 from the FDA. Now what?
Published: 8/22/2024 -
Revisiting Real-World Evidence
Published: 6/18/2024 -
The Most Dangerous Devices to Hit the Market
Published: 6/11/2024 -
Headline-Generating Medical Device Safety Concerns
Published: 5/2/2024 -
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
Published: 3/19/2024 -
Examining Institutional Review Boards
Published: 3/6/2024 -
Reimbursing Breakthrough Designation Products
Published: 1/2/2024 -
Strengthening the 510k Program
Published: 12/19/2023 -
Medical Device Manufacturing Recalls
Published: 10/3/2023 -
AI Predetermined Change Control Plan
Published: 9/19/2023 -
Can You Use a Recalled Device as a Predicate?
Published: 6/20/2023 -
Leading Issues from FDA Inspections (or History Repeating Itself)
Published: 4/4/2023 -
To Regulate or Not to Regulate…LDTs, Part 2
Published: 2/7/2023 -
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
Published: 1/31/2023 -
What Happens When the EUA Period Ends?
Published: 12/13/2022 -
What Does 510k Exempt Actually Mean?
Published: 11/29/2022 -
How Can Off-Label Use Be Promoted?
Published: 11/15/2022 -
FDA's Intended Use Rule’s Relation to Labeling
Published: 11/1/2022 -
Gaining an Advantage Through Class II Special Controls
Published: 10/25/2022
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.