Biomedical Engineering Reference
In-Depth Information
all work. There is one simple reason for this: if you follow a structured design approach then
it is only semantics and not content which is different.
It is worth summarizing what is meant by these terms. ISO 13485:2003 Section 7.3 concerns
design and development of medical devices, specifically:
7.3.1 - Design and Development Planning: all about stages and who does what.
7.3.2 - Design and Development Inputs: clarification phase, building a PDS.
7.3.3 - Design and Development Outputs: records and documentation.
7.3.4 - Design and Development Review: making sure you are doing the right things.
7.3.5 - Design and Development Verification: checking that you've done what you said
you were going to do and that the design meets the inputs.
7.3.6 - Design and Development Validation: Does it do what you said it would?
Evaluation of your design under controlled circumstances; clinical evaluations.
7.3.7 -Control of Design and Development Changes: if you make a change, at any time,
keep proper records .
Now that you have seen the design model, nothing in this list should seem daunting. As each
of the next chapters develops, we shall make sure that we cross-reference the activity versus
these requirements.
Notice that the requirements relate to documentary evidence; they do not tell you how to do
the design.
When an auditor arrives they need to make sure that you have covered these seven
requirements: you need to prove to them that you have done so. The best way to do this is to
lay down procedures and use them. Hence, that is what the next chapter is all about; we are
going to develop procedures that not only help you to design a device but make sure you meet
the regulatory requirements.
3.5 Summary
In this chapter we met several design models. We were introduced to Pahl and Beitz's model,
and Pugh's model. We then explored the fundamental principles contained within them and we
found that it was a divergent-convergent model starting with a fundamental understanding of
the requirements.
This results in the development of a fully populated product design specification. . We were
shown that for it to be robust, it is essential to include all stakeholders in its development.
We then saw that the generation of potential ideas and the reduction of the design space into
a single champion is an essential aspect in making our design process robust. Taking this
potential solution - this embodiment - and making it a reality is the detailed design stage and
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