21 CFR Part 820, ISO 13485​

ISO 13485 is a comprehensive management system that specifically addresses the production of medical devices. The FDA’s equivalent is 21 CFR Part 820, a quality system regulation for all finished products and devices intended for human use. Manufacturers need to ensure that these norms are met by their quality management processes and by all of their suppliers.

GxP, 21 CFR Part 11​

The GxP (Good ‘X’ Practice) guidelines serve as a best practice handbook to help manufacturers comply with data handling regulations rules. ​

21 CFR Part 11 in the FDA’s Code of Federal Regulations defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. It requires companies in the medical industry to implement controls for software and systems that are used to process electronic data regulated by the FDA.