Regulatory Compliance

Regulatory Compliance

The Quality System of Adept Medical Limited complies with the requirements of the Medical Device Directive 93/42 EEC, ISO13485:2003 and CMDCAS ISO13485:2003. Adept Medical is externally audited by SGS UK.

We also meet the requirements of U.S. FDA Good Manufacturing Practices (GMP) and Quality System Requirements (QSR) of CFR Title 21 part 820.

Adept Medical Limited is registered as a Medical Device Manufacturer with the FDA (Registration #3006098219) and with Health Canada (Company ID # 124848).