ISO 9001:2015 Successful Upgrade

17th March 2017

Medical Device Usability have achieved their upgraded accreditation for ISO 9001:2015 with effect from 15th March 2017, 18 months ahead of the deadline. IS0 9001 is a standard designed to set out the requirements for a Quality Management System for business to be more efficient and improve customer satisfaction.  A new version of ISO 9001:2015 […]

Usability research and market research – fundamentally different

16th March 2017

Some of our clients show us past research that they have commissioned from market research companies who sold it to them as ‘usability research’. They even call them ‘formative studies’ and ‘summative studies’. But when you dig into the data, it is market research not usability research. And there is a big different between the […]

Sol’s new arm – latest news

6th March 2017

We are doing our bit to support Ben Ryan as he develops a prosthetic arm for his son Sol. If you’ve been following the story you will know that Sol was born with complications in his left arm, which had to be amputated below the elbow. His Dad Ben gave up his job, and with […]

Threshold analysis and generic combination products

1st March 2017

The new draft guidance from FDA (ucm536959) has introduced a range of new proposals for generic combination products, and one that caught my eye was ‘Threshold Analysis‘. In principle, the idea is a simple on – we simply compare the design of a reference combination product (in effect, the currently marketed product) with that of […]