Verifying the design and use safety of your medical devices.
THAY Medical is an ISO13485 accredited company and a natural choice of partner when developing medical devices, where world–class usability and human factors are required. We specialise in collaborating with organisations to provide the human factors and usability engineering elements that are now critical in maximizing device safety, by performing human factors testing.
For compliance to the US-based FDA human factors guidance, the UK MHRA human factors guidance and IEC 62366-1:2015, performing a formative human factors test is essential, and has to be performed well. For compliance to the European MDR, a formative human factors test is evidence of use safety during the development. Where usability and human factors were variable requirements in the 93/42/EEC Essential Requirements, the new 2017/45/EC Essential Requirements requires evidence of acceptable human factors and usability.
Creating evidence of usability together.
Being the best at formative Human Factors Testing.
THAY Medical are focused on performing formative Human Factors tests to a world-class level. Our customer feedback proves we do this. Our ISO 13485 certified Quality System enables us to do this. We engage with our clients to really understand their medical device, its intended use and all previous development performed on it. In addition, our experience in performing Human Factors and usability tests means we have real expertise in understanding how users are likely to use the device once launched.
We work to all country specific regulations and always perform ethically to the highest standards achievable to give the best quality of data. The test data we produce is minimally biased and trustworthy—purely because we continuously improve our test methods. We are known for high quality Human Factors documentation and compliance to the regulations.
THAY Medical are able to perform all aspects of a formative Human Factors test, or can assist your organisation with specific parts of it—as part of a test team. As a leading service provider in Human Factors Engineering, we excel in performing formative Human Factors tests. We are the partner of choice of many medical organisations, and we can be your partner for all Human Factors testing.