THAY Medical can assist the development of medical devices by providing evidence of use safety to the global standard IEC 62366-1:2015
THAY Medical focus on the human elements of how medical devices are used. We only focus on medical devices, diagnostic technologies and healthcare systems. One focus is the specialist area of Usability Engineering. This science looks at the role of the user in the life of a medical device and how they would be expected to use it. Its core objective is to provide evidence of use safety by researching and evaluating how usable, effective and efficient it is to use. We offer the service of fully providing documentation and evidence of safe use of a medical device using a usability engineering methodology compliant to IEC-62366-1:2015. We are able to perform all aspects required for regulatory compliance, from user research through to formative and summative usability (user) studies.
The Usability Engineering standard (IEC-62366-1:2015) is a structured method of researching, specifying, evaluating and reporting all elements of usability of a medical device. It requires initiation at the beginning of a development or post-market change, which is different to the previous version of the standard. The primary goal of applying this Usability Engineering method is to have enough evidence that the medical device is acceptable in its level of use safety. This is performed in combination with the medical device risk management standard ISO 14971. This includes the following elements: