Because the FDA medical device premarket approval application is the most demanding FDA submission, medical device companies may find it especially difficult to collect, manage, and process the information it comprises for submission and approval.
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MasterControl provides a variety of software solutions that are designed to streamline compliance (FDA, ISO, CLIA, etc.), quality-related processes, training and document management and control. These solutions can be combined, implemented and launched within one integrated platform that can be accessed via the Internet from virtually anywhere in the world. MasterControl provides functionality that is essential for compliance concepts such as deviations management, document management, tracking (audit trails), document location, logistics information, etc. With MasterControl, management of an FDA PMA application and other compliance related documents becomes a far simpler process.
MasterControl provides the following solutions:
Contact a MasterControl representative to learn more about the web-based, electronic software solutions that help streamline the tasks and processes associated with FDA medical device premarket approval submissions.