Medtech Matters

Medtech Matters

Por: 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.
154 episodios disponibles

Latest episodes of the podcast Medtech Matters

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Strengthening the 510k Program 19/12/2023
Medical Device Manufacturing Recalls 03/10/2023
AI Predetermined Change Control Plan 19/09/2023
Can You Use a Recalled Device as a Predicate? 20/06/2023
Leading Issues from FDA Inspections (or History Repeating Itself) 04/04/2023
To Regulate or Not to Regulate…LDTs, Part 2 07/02/2023
To Regulate or Not to Regulate…Lab Developed Tests, Part 1 31/01/2023
What Happens When the EUA Period Ends? 13/12/2022
What Does 510k Exempt Actually Mean? 29/11/2022
How Can Off-Label Use Be Promoted? 15/11/2022
FDA's Intended Use Rule’s Relation to Labeling 01/11/2022
Gaining an Advantage Through Class II Special Controls 25/10/2022
FDA’s Refuse to Accept Policy for 510(k)s 18/10/2022
Initiating a Voluntary Medical Device Recall 11/10/2022
A Letter to File Deep Dive 04/10/2022
Humacyte’s Bioengineered Tissue Platform Technology 08/03/2022
Koya Medical Restores Mobility for Compression Therapy Patients 01/03/2022
NeuroPace’s Aid in Tracking and Treating Epilepsy 22/02/2022
Aidoc Is Improving Patient Outcomes Through AI 15/02/2022
Performing a Gap Analysis on FDA's Regulatory Protocols 08/02/2022
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