
9 changes to FDA goalposts for medical devices
September 5 2018
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…
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 a device accepted by the NHS is often described as something of a “dark art”, a mysterious journey into the unknown. Having a map…
There’s an often overlooked aspect of getting a medical device into the healthcare system (e.g. the NHS in the UK). An aspect that was revealed…
It can be a scary thought, regulatory compliance. So much to get your head around, so much to make sure is done right, and what…
Workshop on Improving the Administration of Paediatric Oral Liquid Medicines using Dosing Syringes and Enteral Accessories 11th September 2018, London, United Kingdom The workshop is…
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…
We are pleased to welcome a new member to our team – Mike Heald. Several of the team have worked with Mike on a number…
Bringing a medical device to market requires significant investment of time, money and resources. In our experience, the precise amounts of all three needed to…
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…
We are delighted to have won a tender to supply regulatory guidance, CE marking and support services to companies developing medical technologies, via the Keele University…