Undertaking medical usability studies compliant with ISO 62366 and HE:75.

Whether it’s the full design and development process, or simply the user testing, PDR can help medical companies comply with international Human Factors and Usability Engineering standards by undertaking formative and summative studies.

Using a risk based approach PDR develops Human Factors and Usability Engineering studies that are rapid, rigorous and compliant with ISO 62366 and HE75 and their integration with wider Design Control processes. Calling upon a broad range of primary research and behavioural analysis tools, including many unique to PDR we have assisted medical device and pharmaceutical companies from around the world. Our approach breaks down the barriers between device development and users in a cost effective way, producing clear insight and evidential data to support development and compliance.

Work relates not only to support with regulatory compliance to US and EU Standards but critically in the translation of insights and findings into more intuitive, safe and commercially successful products with a clear competitive edge.

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Alistair Ruff User Centred Design Lead