FDA QSR Regulations

FDA QSR Quality System Regulation (21 CFR Part 820) Software Solutions for Compliance with Requirements Applicable to Medical Device Manufacturers

The medical device industry is one of the world's most strictly regulated industries. Just to stay in business, medical device companies must comply with a plethora of stringent regulations, including the FDA QSR.

Is your company's documentation FDA QSR compliant?

21 CFR Part 820 – ISO 13485 Harmonization