Category

Medical Devices

The latest posts about #Medical Devices

FDA Electromagnetic Compatibility Requirements Growing
Apr 20, 2021
10
min read
IMDRF’s Five-Year Plan Includes Single Review
Apr 6, 2021
10
min read
FDA STeP Program Offers Expedited Review
Mar 30, 2021
5
min read
FDA Cybersecurity Communications Likely to be Costly
Feb 19, 2021
10
min read
CDRH Wraps Up Guidance for Nitinol Devices
Feb 12, 2021
5
min read
New FDA Intended Use Rule Provokes New Concerns
Oct 22, 2020
10
min read
FDA Opens Digital Health Center of Excellence
Oct 4, 2020
8
min read
Breakthrough Devices May Draw Four Years of Medicare Coverage
Sep 22, 2020
9
min read
SubtleMR Demonstrates How AI Can Fit into the 510(k) Program
Aug 11, 2020
8
min read
FDA, IMDRF Chart Different Courses on Cybersecurity
Jul 28, 2020
7
min read
Combination Products Still a Challenge for FDA
Jul 20, 2020
8
min read
FDA Not Flying Solo in Artificial Intelligence Regulation
Jul 16, 2020
10
min read
Management System Status for ISO 13485 Complicates FDA Adoption
Jun 18, 2020
9
min read
ISO 13485 and Part 820: Delays and Opportunities
May 29, 2020
8
min read
Best Practices for Handling Customer Complaints Post-Market
Mar 23, 2020
5
min read
How the Medical Device Sector Can Support Innovation Methods for Developing Digital Health Products
Mar 16, 2020
7
min read
A Guide to Navigating FDA Device Risk Classifications for New Products
Feb 21, 2020
5
min read
Farewell, Dr. Gottlieb, you will be missed
Mar 7, 2019
3
min read
Creating A Culture Of Quality
Feb 19, 2019
3
min read

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