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FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices

FDA, MHRA and Health Canada Jointly Publish Guiding Principles for Predetermined Change Control Plans for ML-Enabled Medical Devices
medtechintelligence.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from medtechintelligence.com Daily Mail and Mail on Sunday newspapers.

Harnessing digital technologies for universal health

Harnessing digital technologies for universal health
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FDA Updates Electronic Systems in Clinical Investigations Guidance

The FDA updated draft guidance for Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers which revamps recommendations from 2017 on the requirements of 21 CFR Part 11 and use of technologies in clinical investigations.

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