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A Wealth of Experience in Device Testing

Ensuring that a device is safe for the user is paramount for it to receive FDA and EMEA approval. The device needs to be accurate so that the patient can receive optimal treatment and also needs to be easy to use to minimise the risk of use-related errors causing unintended harm.

We have experience in:

  • formative and summative human factors studies
  • studies with patients, consumers, physicians, nurses and pharmacists
  • global expertise including US, European and Asian markets
  • writing research protocols for FDA and EMEA review

When conducting human factors studies it is imperative that the interviewer understands all the intricacies of human factors studies. Therefore we conduct all human factors studies in English speaking markets ourselves whilst we have built up a network of trusted partners in other major markets with whom we regularly work.

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