HirLan, Global Human Factors Testing Experts

Human Factors Testing

Both the FDA and CE Mark require Formative and Summative Human Factors Testing for the approval process. Formative Testing is a smaller scoped test performed at various stages throughout the Product Lifecycle to ensure product development is progressing as desired and catch usability issues early in the process. The successful Summative Test is the final Human Factors Test prior to FDA/CE Mark Approval and product release. The ultimate goal of Human Factors Engineering and all testing is to ensure Safe, Effective and Usable products are introduced to the public.

Formative and Summative Testing enlist the help of all intended users of a product. Were a Summative Test requires a minimum of 15 participants from each user group, a Formative Test is much more flexible using up to 8 participants from a target user group. The FDA requires all Summative Tests to be performed in the US whereas the CE Mark is a little more flexible. Generally, all test participants should not be company employees or associated with the company. Care must be taken when using pediatric and/or geriatric participants as there are ethical considerations. HirLan is experience in all methods and requirements associated with global Human Factors Testing.