Requirements of the Food and Drug Administration (FDA)

PROSYSTEM AG supports manufacturers of medical devices by individual consulting on all issues related to the requirements of the FDA. Rely on our experienced experts in the area of quality assurance, premarket approvals or notifications, registration and distribution for your medical devices in the USA. Benefit from our expertise and our network for communication with the federal agency FDA.
A basic requirement for medical device manufacturers in the USA, is the implementation of a quality management system according to 21 CFR 820 (Quality System Regulation). Manufacturers have to establish and document processes for constructing, manufacturing, packaging, labeling, storage and delivery of medical devices. PROSYSTEM can assist you with the implementation of these and other requirements, such as 21 CFR 11, 803, 806, 308, 821 and 822 in order to prepare you for FDA inspections.