A flurry of activity from FDA

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…

The forgotten twin?

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

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

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

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…

Pain in the arm

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…