Evaluation (Validation and Verification) - Medical Device Design: Innovation from Concept to Market - page 252

9.9 Summary
In this chapter we examined the clinical evaluation phase of the design process. We saw that
it is as important to design this phase as it is to design the product itself. While we recognize
that we may not be able to perform all the tasks ourselves we saw that it was important to
understand what needs to be done.
References
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BSI (2009). BS EN ISO 14971:2009 Medical devices. Application of risk management to medical devices .
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EC (2009). MEDDEV 2.7.1 rev 3 clinical evaluation: Guide for manufacturers and notified bodies . European
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FDA (1997). Design control guidance for medical device manufacturers . FDA.
FDA (2005). Guidance for industry and FDA staff: Format for traditional and abbreviated 510(k)s . FDA.
MHRA (2011). Guidance notes for manufacturers on statistical considerations for clinical investigations of
medical devices . MHRA.