QSR Software and Compliance for Medical Device Quality Management

MasterControl's Quality Excellence is a 21 CFR Part 11 Compliant Software to Automate Quality Systems Outlined in FDA's 21 CFR Part 820 Quality System Regulation (QSR)

MasterControl Quality Excellence helps bio med device companies manage both internal and external quality management and regulatory compliance activities with a variety of customizable quality management solutions.

The medical device industry, among the most heavily regulated industries today, must contend with stringent medical device quality regulations. The FDA quality system regulation (QSR) 21 CFR Part 820 and ISO 13485 are two examples of quality regulation. Medical device quality software systems help ease the burden of regulatory compliance and give companies a competitive advantage.

The Ultimate Guide to Medical Device Quality Management