Welcome to Quality System Connect
This area has been designed specifically for quality system professionals in the medical device manufacturing community. It serves as a resource on educational offerings, standards and publications, and contacts for other groups involved in quality system activities. The site also provides information on FDA and regulations affecting medical device manufacturers.
About the Quality System
- History of the Quality System
- Quality System Regulation and Preamble
- Quality System Technical Amendments
QS & the FDA
- FDA Regulations
- FDA Guidance Documents
- Division of Small Manufacturers, International and Consumer Assistance
- Device Advice

