To distribute a medical device in the US, you as a medical device manufacturer are required to implement and maintain a functioning quality management system. Quality management must meet the requirements of the Code of Federal Regulations (CFR) Title 21 (21 CFR 820 for short).
In the 21 CFR Part 820, the FDA formulates the requirements for the quality management system of medical device manufacturers. Thus, the CFR 21 Part 820 is the American counterpart to ISO 13485.
In many respects, the 21 CFR 820 and ISO 13485 are very similar, senetics helps you identify and implement the differences, preparing you for FDA inspections.
Every medical device manufacturer that sells its products in the US is inspected by the FDA. We prepare you specifically for the course of an FDA inspection and help you to discover nonconformities in your QMS in advance!