21 CFR Part 820 Software

MasterControl's Quality Excellence Provides 21 CFR Part 820 Software Solutions that Help Medical Device Manufacturers Maintain Compliance

Issued by the FDA, 21 CFR Part 820 lays a foundation of Current Good Manufacturing Practice (CGMP) regulations that delineate the processes involved in designing, manufacturing, packaging, labeling, storing, installing and servicing finished medical devices intended for use by humans. The 21 CFR Part 820 software solutions offered by MasterControl's Quality Excellence expressly designed to streamline and enhance medical device development while sustaining regulatory compliance.

21 CFR Part 820 – ISO 13485 Harmonization