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.
Templates standardize your submissions and equip your organization with constant readiness. This gives you a head start for every registration.
510(k) submissions software makes sure your submissions registrations are ISO compliant.
Don’t let the 510(k) submissions process manage you. Submissions software can help manage and expedite your device registrations.Download the Data Sheet