9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a…

Getting your medical device into the NHS

Getting a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown.  Having a map…

Riding the wave of Software as a Medical Device

For years there’s been an indistinct, blurry area, surrounding software and apps that are deemed medical devices and so called “wellness” or “lifestyle” applications. Signs…

Welcome to the team, Mike

We are pleased to welcome a new member to our team – Mike Heald.  Several of the team have worked with Mike on a number…

Navigating the transition

The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017. Understanding the changes, let…