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Traceability of requirements to design and risk

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yodon

Staff member
Super Moderator
#2
#2
Short answer: YES!

Generally speaking, you'll have a set of user needs (high-level, basis for validation) and these drive (and trace to) system requirements (written such that they can be verified). In parallel, you have risk management work and the controls also drive (and trace to) system requirements. (It can get substantially more complex, especially if software is involved but that's the gist.) Risk controls need to be demonstrated to be implemented (often through verification) and effective (often through validation).
 
chris1price

chris1price

Trusted Information Resource
#4
#4
Per ISO13485:2016....

7.3.2 e) (During design and development planning, the organization shall document) .....the methods to ensure traceability of design and development outputs to design and development inputs;

7.3.4 The outputs of design and development shall be in a form suitable for verification against the design and development inputs and shall be approved prior to release.

So as Design Inputs should be related to your risks, as Yodon says YES
 
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