The Applied Technical Services Family of Companies (ATS FoC) is a trusted provider of predicate device compliance testing services. The global medical device market is steadily expanding as demand rises and technology evolves. As the market grows, new medical device manufacturers will arise and offer consumers new products built upon established platforms and technologies. Our services help medical device manufacturers ensure their device’s compliance with US and European Union (EU) regulations.
What is a Predicate Device?
A predicate device is a legally marketed medical device that is a benchmark for evaluating a new device’s safety and effectiveness. In the US, predicate devices are requiresto justify that the subject device is “substantially equivalent” to a device already legally approved for sale. Predicate devices are part of the FDA’s 510(k) clearance process for Class II devices, which is a regulatory pathway that requires manufacturers to show their device is substantially equivalent to a predicate device in area such as indications for use, technological characteristics, sterility, biocompatibility, and mechanical strength. Under the EU Medical Device Regulation (MDR), a predicate device is a lawfully marketed device with valid CE marketing. The MDR requires manufacturers to demonstrate that their proposed device is equivalent to a predicate device with respect to its clinical, biological, and technical characteristics.
About Our Predicate Device Compliance Testing Services
Our medical device testing team provides strategic predicate device testing services that help clients navigate the complexities of the FDA 510(k) and MDR pathways with confidence. Our services help streamline the approval process by helping our clients ensure their device’s compliance with relevant standards.
Contact Us
Call +1 (888)-287-5227 or submit a web request form to learn how we can support your next medical device submission.

