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At the heart of our product design and development process lies Usability & Human Factors Engineering.

We ensure that all products developed through our internal processes comply with key standards such as IEC 62366-1, ISO 14971, and guidance from MHRA & FDA.

Understanding the needs of a user group is crucial in generating fundamental and meaningful user requirements for development; here at Medical Design Group, we integrate Risk Management with Human Factors & Usability Engineering to adopt a user-centred approach in designing and developing medical devices. This approach guarantees that the products we create can be used safely and efficiently under real-world conditions.

Medical Design Group offer a full solution to Usability & Human Factors Engineering and are positioned well to fast-track iterative designs based upon user feedback.

We have an extensive network and a rich pool of resources for recruiting participants for formative & summative studies alike.

Our team of Usability & Human Factors Engineering experts can assist at any stage of a development, with the ability to produce:

• Use Specifications
• Task Analysis (“Fault Tree Analysis” per FDA Guidance)
• Hazard related use scenarios (Use-FMEA)
• User Interface Specifications
• Process Flow diagrams for digital, electronic and mechanical designs, systems & interfaces
• Usability Plans, study coordination & management, Technical Reports and updates to Risk Management documentation

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