Quality Systems Regulation

The current Good Manufacturing Practice (GMP) requirements set forth in the Quality System (QS) regulation (21 CFR 820) require that domestic or foreign manufacturers have a quality system for the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for commercial distribution in the United States. The FDA also describes the quality system requirements in detail.

Contact Us

Find us on LinkedIn

  • LinkedIn

 Salt Lake City, Utah

© 2023 by ITG. Proudly created with Wix.com