Startups Push The Limits Of MedTech, But Must Check FDA Compliance
The Startup Magazine
JANUARY 8, 2019
In 1997, the FDA passed something known among compliance experts as 21 CFR Part 11 – or Code of Federal Regulations title 21, part 11 of which covers electronic records and signatures, but back in 1997, healthcare computing was a much less complex area, and 21 CFR has since been clarified. Computing Concerns.
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