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…
Archive
Rising cost of compliance for medical devices in Canada
May 15 2018
Our recent insight post highlighted a key change in Health Canada’s requirements for companies seeking authorisation to market their devices. A change that is leading…
Riding the wave of Software as a Medical Device
May 8 2018
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…
ISO 13485:2016 – time is running out
May 1 2018
Something may have escaped your notice in the talk about the revised version of ISO 13485, published in 2016 (ISO 13485:2016 is the International Standard…
Updated – fifteen things you need to know about the Medical Device Regulation
October 18 2017
Update: Since we first published the 15 things, the Medical Device Regulation has moved on apace: The MDR was approved by the European Parliament on…
Navigating the transition
September 5 2017
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…
Business Bridge tender success for Three Circles!
August 30 2017
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…
Self-certification, what’s the Medical Device Regulation done with it?
May 15 2017
There’s a heart stopping moment in store for manufacturers of low risk, non-invasive medical devices! The EU Medical Device Directive contained a number of Annexes…
The Cupboard of Shame
September 14 2016
Many people like to be able to present a clean, well-ordered home when they are expecting visitors. Some even prefer to have their home “inspection…
Medical device development; look what you could have won…
July 13 2016
Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…) Three Circles, the leading medical device development consultancy,…