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…

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…

ISO 13485:2016 – time is running out

Something may have escaped your notice in the talk about the revised version of ISO 13485, published in 2016 (ISO 13485:2016 is the International Standard…

Navigating the transition

The countdown clock to the application of new EU Medical Device Regulation (MDR) started its three year life in May 2017. Understanding the changes, let…

The Cupboard of Shame

Many people like to be able to present a clean, well-ordered home when they are expecting visitors. Some even prefer to have their home “inspection…