Regulatory Brief

An overview of 21 CFR Part 11 regulations for medical device companies

The U.S. federal regulation that addresses electronic records and signatures is important for medtech companies with FDA-regulated products. For these companies 21 CFR Part 11 impacts every document, process, and submission. Read our free regulatory brief for a background on the regulation and how medtech companies can achieve compliance.

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An overview of 21 CFR Part 11 regulations for medical device companies

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