A flurry of activity from FDA
February 5 2016
It’s been a busy week for the US Food and Drug Administration’s CDRH. In the space of a couple of days, the Center has published…
Archive
The forgotten twin?
January 27 2016
Human Factors and Usability are “hot topics” in the medical device world (and increasingly for drug/device combination products too), yet the concept and the disciplines…
Human Factors high on FDA Priorities for 2016
January 20 2016
So, the FDA’s Center for Devices and Radiological Health (CDRH) have included Human Factors in their 10 priorities for 2016 and Regulatory Science. There have…
CDRH New Year’s resolutions
January 13 2016
The FDA has shared its New Year’s resolutions, including the guidance documents the Center for Devices and Radiological Health intends to publish in 2016. In…
Top 5 posts of 2015
January 6 2016
During 2015 we dipped our toe in the water, posting thoughts and tips both on our website and LinkedIn Pulse. At the close of the…
MHRA developing human factors guidance for medical devices
December 10 2015
UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious…
Pain in the arm
December 2 2015
Whilst visiting a local pharmacy recently, I came across a notice that free flu jabs were available for qualifying NHS patients. This seemed like a…
Back by popular demand – one day seminar on Human Factors and Medical Devices
November 25 2015
Developing medical devices that really meet users’ needs will give you a distinct competitive advantage. Following a robust development process that is focused upon the…
Usability study leads to key medical device design improvements
October 14 2015
A team from Three Circles recently completed a 2 week long formative usability study for a medical device in Europe. The study was typical of…
Closing the gap between EU and US Human Factors requirements
September 23 2015
Medical device manufacturers can have a tough time gaining approval of new devices in the US, due to the increased scrutiny of the usability aspects…