Richard is a freelance usability consultant with over 20 years of experience in providing expert usability / human factors consultancy and training to MedTech and pharmaceutical clients in the UK, US and Europe. He primarily works on preparation of technical human factors data, preparing submissions for regulatory review by the US and European authorities, and responding to questions raised by the regulators.

Areas of speciality

• Usability Engineering technical documentation for MedTech and combination products to IEC62366.
• Preparation of technical usability submissions for FDA and Notified Body review.
• Interface between Usability Engineering and Design Controls, quality management systems and ISO13485
• Use-related risk management to ISO14971
• Usability requirements within the clinical trials program for IND and IDE
• Usability testing - formative and summative