What A Difference A Medical Device Can Make
March 16 2016
This week, a guest post… John Lennon famously said, “Life is what happens while you are busy making other plans”. And so it did. I…
Archive
FDA finalises Human Factors Guidance – Existing products – Part 4
March 9 2016
In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to…
FDA Finalises Human Factors Guidance – summative testing – Part 3
March 2 2016
In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to…
FDA finalises Human Factors Guidance – Part 2
February 24 2016
In this series of posts, we’re taking a look at the recently published final version of CDRH’s guidance “Applying Human Factors and Usability Engineering to…
FDA finalises Human Factors Guidance – Part 1
February 10 2016
We’re just over a month in to the year and the FDA’s CDRH have published a final version of their guidance “Applying Human Factors and…
A flurry of activity from FDA
February 5 2016
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…
The forgotten twin?
January 27 2016
Human Factors and Usability are “hot topics” in the medical device world (and increasingly for drug/device combination products too), yet the concept and the disciplines…
Human Factors high on FDA Priorities for 2016
January 20 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
January 13 2016
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…
MHRA developing human factors guidance for medical devices
December 10 2015
UK regulatory authority the Medicines and Health products Regulatory Agency (MHRA) has started to develop guidance on human factors for medical devices. We are curious…