Tag: Europe Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Device

USA Guiding Principles on Predetermined Change Control Plans for Machine Learning-Enabled medical devices FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded,...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Device

USA Electronic Submission Template for Medical Device 510(k) Submissions The FDA Electronic submission template for medical device guidance describes the technical standards associated with...

Europe Regulatory News, IVDR, MDR, Medical Devices, Regulatory News, USA Regulatory News

Medical Devices-USA/Europe Regulatory News-September 2023

Medical Device

USA (FDA) Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators,...

CE marking, Europe Regulatory News, in vitro diagnostics, Medical Devices, Regulatory News, USA Regulatory News, vigilance

Pharma/Biotech – USA, Europe Regulatory News, Jan 2023 Vol. 1

Biopharma

EU EMA recommendation paper: Safety, data integrity key to decentralized trial conduct The European Medicines Agency (EMA), European Commission (EC), and Heads of Medicines Agencies (HMA) recently...

BioTech, Europe Regulatory News, Pharma, Regulatory Updates, US Regulatory News

Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

Medical Device

EUROPE 1. Updated Information Pack for Candidate EU Reference Laboratories Regulation (EU) 2017/746 authorizes the European Commission to designate EU reference laboratories for specific devices...

Canada Regulatory News, Europe Regulatory News, Ireland Regulatory News, Medical Devices News, UK Regulatory News, USA Regulatory News

Tag: Europe Regulatory News

Medical Devices-USA/Europe Regulatory News – Nov 2023

Medical Devices-USA/Europe Regulatory News-October 2023

Medical Devices-USA/Europe Regulatory News-September 2023

Pharma/Biotech – USA, Europe Regulatory News, Jan 2023 Vol. 1

Medical Devices-USA/Europe Regulatory News Roundup, Nov 2022

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