Human Factors

15 things you need to know about MHRA Human Factors expectations

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 device development; look what you could have won…

Medical device development; look what you could have won…

Would you like our eternal gratitude… and a small scale model of a speed boat? (yes, really…) Three Circles, the leading medical device development consultancy, have commissioned bespoke research into the industry’s perceptions of best practice, areas of risk, and the...

Have you taken these steps to make your medical device safe?

Have you taken these steps to make your medical device safe?

Pressures to get to market quicker haven’t eased up any over the past year. Everyone’s looking for an advantage to press home. Developing medical devices that really meet users’ needs will give you that competitive advantage. And, given how many people die in...

Three ways to smooth your path for device development

Three ways to smooth your path for device development

Spring of 2013 still seems recent, so I was surprised to realise that the route map for medical device development will shortly be 3 years old. If it were a child in the UK, we would be able to get 15 hours free childcare a week from this September. Children learn and...

What A Difference A Medical Device Can Make

What A Difference A Medical Device Can Make

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 had planned a week of developing ideas, gathering data for a project, business meetings and so. Then life struck. With a bladder that...

FDA finalises Human Factors Guidance – Existing products – Part 4

FDA finalises Human Factors Guidance – Existing products – Part 4

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 Medical Devices”. The document, published on 3 February, is the result of nearly 5 years of consultation with...

FDA Finalises Human Factors Guidance – summative testing – Part 3

FDA Finalises Human Factors Guidance – summative testing – Part 3

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 Medical Devices”. We have already taken a look at the first three in this list of the key topics covered by the...

FDA finalises Human Factors Guidance – Part 2

FDA finalises Human Factors Guidance – Part 2

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 Medical Devices”. In part 1, we looked at both the Human Factors Engineering process and Risk Management and...

FDA finalises Human Factors Guidance – Part 1

FDA finalises Human Factors Guidance – Part 1

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 Usability Engineering to Medical Devices”. The document, published on 3 February, is the result of nearly 5 years of consultation...

A flurry of activity from FDA

A flurry of activity from FDA

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 one final and two draft guidances related to Human Factors. Just over a month into 2016 and the Center has already achieved 3 of its...