Articles About Regulatory News
Regulatory news and other exciting things happening in the regulatory world. Generally speaking, most updates here are about how your life is about to get more complicated and you’ll be writing even more documentation. But there are some much-appreciated exceptions!
No, Telemedicine Software Is Not Class IIa Under The MDR
Regulatory News
MDR Class I
MDR Classification
January 25, 2024
Brace for Impact: The New MDR Transition Periods
Regulatory News
August 15, 2023
July 2023 Updates: New Usability Articles, MDCG Q&A On Transition, Open Source QMS Software
Regulatory News
July 21, 2023
Maybe Harmonized Standards Are Becoming Freely Available Soon
Regulatory News
Accessing Standards
July 7, 2023
The IVDR Might Require 264 Notified Bodies
Regulatory News
January 17, 2022
ISO 13485 Amendment, Templates, User Manuals
Regulatory News
December 17, 2021
MDR Classification Chaos and User Manuals
Regulatory News
December 7, 2021
OpenRegulatory Newsletter #1: Conference
Regulatory News
September 12, 2021