Medtech Matters
En podkast av Medical Product Outsourcing - Tirsdager
Kategorier:
143 Episoder
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What is a CAPA and How Do You Best Use It?
Publisert: 3.9.2024 -
You Got a 483 from the FDA. Now what?
Publisert: 22.8.2024 -
Revisiting Real-World Evidence
Publisert: 18.6.2024 -
The Most Dangerous Devices to Hit the Market
Publisert: 11.6.2024 -
Headline-Generating Medical Device Safety Concerns
Publisert: 2.5.2024 -
Analyzing ECRI’s 2024 Top 10 Health Technology Hazards
Publisert: 19.3.2024 -
Examining Institutional Review Boards
Publisert: 6.3.2024 -
Reimbursing Breakthrough Designation Products
Publisert: 2.1.2024 -
Strengthening the 510k Program
Publisert: 19.12.2023 -
Medical Device Manufacturing Recalls
Publisert: 3.10.2023 -
AI Predetermined Change Control Plan
Publisert: 19.9.2023 -
Can You Use a Recalled Device as a Predicate?
Publisert: 20.6.2023 -
Leading Issues from FDA Inspections (or History Repeating Itself)
Publisert: 4.4.2023 -
To Regulate or Not to Regulate…LDTs, Part 2
Publisert: 7.2.2023 -
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
Publisert: 31.1.2023 -
What Happens When the EUA Period Ends?
Publisert: 13.12.2022 -
What Does 510k Exempt Actually Mean?
Publisert: 29.11.2022 -
How Can Off-Label Use Be Promoted?
Publisert: 15.11.2022 -
FDA's Intended Use Rule’s Relation to Labeling
Publisert: 1.11.2022 -
Gaining an Advantage Through Class II Special Controls
Publisert: 25.10.2022
A podcast focused on the medical device technology industry, from design and development to outsourcing services and relationships to finished medtech products.
