ISO 13485:2016 – time has run out!

You’ll probably recall me mentioning ISO 13485, and its relevance to ensuring that you don’t fail? If you’ve reached the conclusion that it would be…

Another week, another funding opportunity

Hot on the heels of last week’s article, there’s a further opportunity to get some funding to support your development project. This time, the criteria…

9 changes to FDA goalposts for medical devices

A potential silver lining for medical device developers and manufacturers exists in the FDAs response to 2016 “21st Century Cures Act”, with publication of a…

FDA Quality System Regulation and ISO 13485

A ray of sunshine has appeared for medical device developers seeking to market their devices in the US as well as other territories. Often, manufacturers…

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…