Change Control Software for Medical Devices

21 CFR Part 11, Part 606, and Part 211 GMP Compliant Medical Device Change Control Software Systems

In FDA and ISO environments, the concept of change control is closely interwoven with compliance. Under the FDA's Quality System Regulation (QSR) for medical device companies ( 21 CFR Part 820 ), a medical device change control software system is required for design changes ( 820.30 ), document changes ( 820.40 ), and production and process changes ( 820.70 ).

The MasterControl medical device change control system is an integrated quality management software solution suite that is configurable, easy to use, and helps medical device companies attain and sustain compliance.

Ensure Compliance by Digitizing Change Control