THAY Medical are well-known for performing high-quality summative-level human factors tests. We perform them frequently in many countries on many types of medical devices. Performing summative-level human factors tests is a regulatory requirement in the development of medical devices. Compliance is paramount to the latest regulations in usability and human factors engineering. We guarantee compliance, and we continually improve our ISO 13485-certified test methods.
Summative tests are performed at the end of the design process – once the device design is final, and is performed using production-level devices. This testing requires a larger sample size than often used in formative testing. In addition, it is a prediction tool – to determine how safe to use the device is likely to be when subjected to its real life human factors – use environments, use situations, use-based hazards, interacting systems and intended users.
Summative tests are performed to validate many elements of the design of a medical device – the usability of the device; the readability and comprehension of the instructional materials and labelling; the use safety of how it is intended to be used; and the training methods planned for implementation at launch. This is laid out in the regulatory guidelines which THAY Medical are compliant to – IEC 62366-1:2015; ISO 9241:2011, IEC 60601-1-6:2010, the US-based FDA CFR Title 21, 820.30 and the UK MHRA guidance from September 2017.Depending on the level of compliance required, THAY Medical will tailor the testing to suit.
The process shown above is a simplified version of what we do to performed a summative test. It is a compliant process that aims to be efficient – value for money and timely. A typical summative test takes 6-12 weeks to perform depending on the number of user groups, training regime, test location and the complexity of the medical device. Summative tests start from £9,000 / € 10,500 / $12,000 when using THAY Medical. We aim to be competitive and always deliver our summative tests on time, to budget and always meeting our customer requirements.