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Capturing the implicit and explicit requirements of the product is critical to designing something that will succeed in today’s competitive marketplace. Our team of medical device experts help capture these inputs, both the more nebulous user requirements and the detailed technical requirements, including the outputs from the Risk Management process and translate them into clear succinct statements.

Ensuring these statements are SMART (specific, measurable, achievable, relevant and time-bound) such that they can be verified or validated.

Iterative process and design review.

The design input requirements are then used in the later stages of the development process to ensure that not only is the product designed right – but the right product has been designed.

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