15 things you need to know about MHRA Human Factors expectations
Medical Device Alliance member Three Circles recently identified 15 things you need to know about MHRA Human Factors expectations.
We now have official guidance for Human Factors and Usability Engineering in a member state of the EU.
19th September 2017 saw publication of official guidance from MHRA (the UK medicines and medical devices regulator) for Human Factors and Usability Engineering for medical devices and drug-device combination products. You may recall that the agency published a draft document for consultation in mid 2016. The final document extends to 47 pages and includes many changes as a result of consultation responses.
While of detailed interest to people working within human factors, everyone else probably wants to find out “what does it mean for me?”
So, here are 15 things you need to know about the MHRA guidance:
MHRA’s newly released final guidance emphasises its applicability to all classes of medical devices and device-drug combination products, there’s absolutely no avoiding usability engineering.
Content of the guidance appears closely aligned with FDA… [to read the full article, click here to visit its home at Three Circles]