Medical Device Document Control Software

The Medical Device Document Control Software from MasterControl Ensures Compliance with FDA's QSR 21 CFR Part 820 and ISO 13485 Quality Standards

Document control is an integral part of the Quality System Regulation outlined in 21 CFR Part 820. Specifically, Section 820.40 requires medical device manufacturers to establish and maintain procedures that will control documents and to designate one or more individuals to review and approve documents prior to issuance. Records of changes made to documents should be maintained, including a description of the change, identification of affected documents and signature of the approving individual. 21 CFR Part 11 works in tandem with predicate rules such as 21 CFR 820. These regulations apply to medical device document control software systems.

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