21 CFR 820 – FDA Medical Device GMP
21 CFR 820, also known as medical devices GMP (current Good Manufacturing Practice), are the quality system regulations for medical devices. Even though US FDA develops GMP, FDA does not issue a GMP Certificate, nor does FDA recognize a GMP certificate issued by the third-party certification body. FDA site audit is based on 21 CFR 820 regulations.
Domestic and foreign organizations that manufacture or market medical devices in the USA must comply with 21 CFR 820 requirements. The main components of GMP are quality manual and quality system procedures. Proper implementation of a quality management system will help an establishment avoid warning letters after the FDA audit.
If you are looking for assistance in 21 CFR 820 implementation, GAP analysis, or FDA 483 support, LMG can help you. Our experienced consultants can equip you with FDA inspection requirements.
Our Services Included with
- Quality Manual
- Quality system procedures
- Internal audit
- GAP Analysis
- FDA audit support
- 21 CFR 820 Maintenance