Medical Device Quality System Regulation Audits

Under 21 CFR Part 820 the Quality System Requirements, or Good Manufacturing Practices (GMPs), includes requirements related to the methods used in and the facilities and controls used for designing, purchasing, manufacturing, packaging, labeling, storing, installing and servicing of medical devices. Manufacturing facilities undergo FDA inspections to assure compliance with the QS requirements. Because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Rather, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device. EAS consultants provide a detailed understanding of the specific QSR – GMP requirements for your specific medical device, ensuring compliance with the most applicable regulations.