Tag: FDA Compliance

21 CFR 820.30

April 23, 2023 · 2 min read

21 CFR 820.30

21 CFR 820.30 is a regulation that outlines the requirements for design controls for medical devices in the United States. The regulation applies to…

CFR Part 11

April 23, 2023 · 1 min read

CFR Part 11

refers to the electronic records and electronic signatures regulations set forth by the US Food and Drug Administration (FDA) under Title 21 of the…