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FORMATIVE STUDIES

 

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

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SUMMATIVE TESTING

 

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

COMPLIANCE

THAY Medical have the expertise to fully perform human factors studies to ensure the optimum outcomes are achieved. We as a minimum achieve compliance to the current regulations and best industry standards such as UK MHRA, ISO & FDA. Please click the below links to the guidance on applying human factors to medical devices .