FDA 21 CFR Part 820 QSR Requirements

Quality System Regulation (QRS) requirements are set up to ensure medical devices are high quality, safe and effective.

21 CFR Part 820 outlines the current good manufacturing practice (CGMP) guidelines for developing medical devices. It governs the methods, facilities and controls used for medical device design, manufacture, packaging, labeling, storage, installation and service.

21 CFR Part 820 – ISO 13485 Harmonisation