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…

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…

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…

Is herding cats easier than Design Controls?

With increasing pressures on healthcare businesses to get to market quicker and pressure to lower development costs, managing your design controls activities effectively has never…