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


The 510(k) submissions solution allows you clear visibility of the countries and regions where a device is registered. The tool provides macro and micro views of projects so you don’t miss critical deadlines.


Project Management


A 510(k) digital solution eliminates manual and hybrid processes to efficiently manage all 510(k) submissions. This streamlines the process of compiling, reviewing and approving documents. The software can also be integrated with quality management or other systems to facilitate collaboration.


Consistent Filings


510(k) submissions software prevents complex registrations for different markets leading to inconsistent filings and fragmented data. Templates and checklists ensure consistent filings throughout your organization regardless of location. 

Trusted By


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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