Our Blog

December 2, 2022

All you need to know about a Premarket Approval (PMA) Submission — Route to the US Market for Class III medical devices

The Federal Food Drug and Cosmetic (FD&C) Act established three regulatory classes for medical devices – Class I, Class II, and Class III,  in order to ensure that the devices are...

September 21, 2022

Accelerated pathway to the market – The know-how of Breakthrough Device Designation Request

A medical device manufacturer approached Elexes with a very unique medical device. While the product had a lot of advantages over any other treatment option in the target clinical area, the manu...

June 3, 2021

Postmarket Surveillance: An inescapable sound of noise

Are you a Medical Device Manufacturer? an employee of a medical device company? Or perhaps someone with an interest in Medical Devices. If yes, then postmarket surveillance is something critical...

pma submission
March 17, 2021

PMA Submission

Medical devices that have a high risk associated with them require a pre-market approval (PMA). A PMA is a detailed document that requires clinical data to substantiate the claims made for a par...