Zen and the Art of Design Controls

There are days when I think “is it me?” Especially when it comes to appreciating Quality Systems. I confess I do like logic and I…

Industry homes in on Human Factors

The move of a former US Food and Drug Administration (FDA) employee to one of the world’s biggest pharma companies signals a recognition at a…

Finding a nutcracker

Medical device use is rapidly moving outside hospitals and clinics. Changing use opens up the possibility of increasing patient comfort and convenience of treatment, with…

The train at platform 9 and 3/4

We’ve been on a road trip recently, sharing a way of encapsulating the key steps of device development that has been attracting “rave reviews”. I’d…

4 steps to (device) heaven

After I wrote about the MDA’s approach to device development (here’s the post), several people emailed me to find out more. Perhaps, like them, you’re…

The directives are a-changing

A long awaited proposal for revisions to the EU Medical Device Directives was published on 26 September. The revisions aim to address a range of…