FDA PMA - Medical Device Premarket Approval


An FDA PMA application is key to obtaining FDA approval and permission to market Class III (and some Class II) medical devices.

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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How does FDA Medical Device Premarket Approval work?

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 FDA PMA (Premarket Approval) Solutions

MasterControl provides the following solutions:

  • MasterControl Documents
  • MasterControl Processes
  • MasterControl Nonconformance
  • MasterControl Deviations
  • MasterControl Customer Complaints Handling
  • MasterControl Audit
  • MasterControl Equipment Calibration
  • MasterControl Equipment Maintenance
  • MasterControl CAPA
  • MasterControl Projects
  • MasterControl Change Control
  • MasterControl Training

For More Information on FDA Medical Device Premarket Approval

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.