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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...
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...
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
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...