510k Submissions Software System

510(k) Submissions Software

MasterControl’s 510(k) submissions software helps ensure your device submissions are connected, efficient and compliant.

Obtaining the FDA’s 510(k) clearance or premarket approval (PMA) for a medical device is a complex and nerve-wracking process. And that’s just in the United States. If your company wants to market a device in other countries in addition to the U.S., the requirements increase exponentially. Med device firms are increasingly using 510(k) submissions software systems to help ease the burden. MasterControl Registrations is a complete solution for product registration and 510(k) device submission management that automates system processes and tracks requirements for each geographic location.

MasterControl Registrations™

Take the headaches out of 510(k) submissions with a solution that manages submissions processes and requirements.


Project Visibility


Project Management


Consistent Filings

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Find out how a 510(k) software solution can organize your submission documents more effectively to meet critical deadlines.

Templates standardize your submissions and equip your organization with constant readiness. This gives you a head start for every registration.


Learn how a 510(k) solution that integrates ISO standards can help ensure efficient regulatory management of your submissions.

510(k) submissions software makes sure your submissions registrations are ISO compliant.

Streamline your 510(k) submissions with an automated solution that accelerates the process.

Don’t let the 510(k) submissions process manage you. Submissions software can help manage and expedite your device registrations.

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