Top 5 CRF 21 Non-Compliance Citations – and How to Avoid Them

The latest MD+DI webinar, sponsored by Limble and available now on demand, covers the importance of the 21 CFR (Code of Federal Regulations) for medical device manufacturers and the five most common non-compliance violations (and how to avoid them).

The 21 CFR is a set of FDA regulations designed to ensure the safety and efficacy of certain products and industries (such as medical devices). Frequently, manufacturers in industries subject to the 21 CFR must face an audit, during which FDA auditors will review your company's records and documentation. Specifically, they'll be looking for a lack of documentation, and if they can't find certain documentation about maintenance procedures or tasks, it will be marked as noncompliance.