Regulatory

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.

Free Resources

Reducing the Documentation Burden in FDA Design Control

Product Videos

Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

Video Title
Video Title
Video Title

Free Resources

Select all the resources you’re interested in downloading

Industry Brief: 8 Best Practices for Compliant and Quick Software Validation in the Cloud Industry Brief: Reducing the Documentation Burden in FDA Design Control
White Paper: Engineering and Quality Teams in Medical Device Firms: Can We All Get Along?
Q&A: FDA Medical Device Investigator Offers Insights on Inspection
Analyst Report: A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences (LNS Research)
Solution Overview: MasterControl Clinical Excellence Solution Overview: MasterControl Regulatory Excellence
Trend Brief: 2024 Medical Device Industry Trends

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.