Riding the wave of Software as a Medical Device

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…

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…

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…

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…