In approximately one years’ time, the European Medical Device Regulation 2017/45/EC (MDR) becomes enforced upon medical device manufacturers and pharmaceutical organisations. With this regulation coming into force, there is requirement for these companies to ensure that the usability and human factors evidence is relevant and to a level that satisfies the revised Essential Requirements. And…Details
THAY Medical are an ISO-13485 certified Human Factors Engineering organisation who focus purely on Medical Devices, Technologies and Software. We assist companies to gain and keep their compliance, understand their intended users and develop world-class Medical Devices,.
We perform Human Factors Engineering and Usability Testing around the world to ensure the Medical Devices we interact with are safe, and usable, and provide the intended users with that positive user experience they need!
Usability & Human Factors Testing for Medical Devices
If you have a medical device or medical software that has not been through any form of independent Usability Testing or Human Factors Engineering - we can do this for you!
We perform Human Factors Engineering and Usability Testing around the world to ensure the intended user is fully understood. We mainly focus on European and US-based testing but are able to test your medical device nearly anywhere!
Usability Engineering and Regulatory compliance
THAY Medical have an ISO 13485 certified Quality System based around the three usability standards used currently - IEC 62366-1, the US-based FDA Guidance and the UK-based MHRA Guidance. This means we are competent in using these regulations to perform Usability Testing and Human Factors Engineering for medical devices, and we continuously improve our methods to be the best.
We’re proud and honoured to be sponsoring and volunteering at this years Teddy Rock festival, raising money to support a great cause! Teddy Rocks is an amazing story that started in 2011 as a small gig in a pub in Blandford. Just 6 years on, the festival has grown enormously to a full weekend camping…Details
THAY medical had a great day at the annual Injectable Drug Delivery conference last week. The conference was held by the Management forum in London on the 28th & 29th of March. As well as presenting ourselves, we got to hear some great speakers with useful insight over the course of the 2 day conference.…Details