510k and PMA Submissions

Organizing and submitting a 510k or PMA application can be difficult and the repercussions of an incomplete application can include millions of dollars wasted due to delays in product-to-market operations.

Manage a 510k or PMA Submission and More with MasterControl

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.

Watch Videos View Medical Device 3-Minute Demo (3:00) Creating a Paperless Process Using MasterControl (3:38) BioMimetic Therapeutics (8:36)

510k and PMA Submissions and the Quality Systems Regulation

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:

• MasterControl MD
• MasterControl Documents
• MasterControl Forms
• 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

MasterControl 510k and PMA Submissions Validation

In addition to software solutions that help streamline preparation for 510k submissions, MasterControl also provides validation services and the following additional services:

• Implementation
• Training
• Technical Support
• Project Management

For More Information on 510k and PMA Submissions

For more information regarding streamlined preparation for 510k and PMA submissions, please feel free to contact a MasterControl representative.