Requirements to bring a medical device to market-Reference-Cited by-同舟云学术

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Requirements to bring a medical device to market

Published:2024-08 Issue: Volume: Page:
ISSN:0167-7799
Container-title:Trends in Biotechnology
language:en
Short-container-title:Trends in Biotechnology

Author:

Buenz Eric J.^ORCID,Wallace Victoria M.,Levy Friedman Suzanne

Publisher

Elsevier BV

Reference15 articles.

1. Estimated cost of developing a therapeutic complex medical device in the US;Sertkaya;JAMA Netw. Open,2022

2. The Biomedical Entrepreneurship Skills Development Program for the Advancement of Research Translation: Foundations of Biomedical Startups course, metrics, and impact;Schweickart;J. Clin. Trans. Sci.,2023

3. FDA regulation and approval of medical devices: 1976-2020;Darrow;JAMA,2021

4. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices;Dhruva;JAMA,2009

5. Radiological medical device innovation: approvals via the premarket approval pathway from 2000 to 2015;Ghobadi;J. Am. Coll. Radiol.,2017

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