MasterControl provides document control software which fits into a more extensive suite of GxP process management software solutions that manage 510k and PMA documentation (and any other type of document), manage regulatory submissions and simultaneously connect the concept, feasibility, definition, development, commercialization and marketing phases of product evolution.
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A 510k or PMA submission is handled more effectively when it is prepared using electronic document control software and when software solutions are utilized to streamline compliance with governing QSR (Quality Systems Regulation) requirements. MasterControl allows medical device companies to collaborate, track, automatically route, analyze and report on submission related documentation while simultaneously streamlining compliance (for QSR requirements) with the following software solutions:
In addition to software solutions that help streamline preparation for 510k submissions, MasterControl also provides validation services and the following additional services:
For more information regarding streamlined preparation for 510k and PMA submissions, please feel free to contact a MasterControl representative.