Standards and norms are the great unknowns of design. This is largely because standards are generally described in an extensive and unpalatable way. To add to this most designers work in a narrow product area and so only understand what they are familiar with.
While previously, in-plant development departments had a standards officer who knew the relevant standards and maintained an updated standards manual, a lack of standards knowledge in today's fast and often outsourced development processes means this issue is encountered more and more frequently.
Today this responsibility must be taken on by the product or project manager who must be familiar not only with the standards of the product but also must be able to judge whether there is sufficient expertise in the development team. One of the benefits of standards is that there is little room for interpretation, standards are more often than not the law and so must be adhered to strictly. Failure to comply is almost always identified, however if discovered too late in the process this can have crippling effects.
What standards the product must adhere too must be continuously considered throughout the development. Are there relevant standards for electrical safety or specific standards? Take for example the risk classification of medical devices according to the European CE standard or North American FDA. This has an impact when a product is first launched in one country and then launched in another region or country in the future, was this new market’s regulations considered during the development of the product?
In the medical device development category this even goes one step further. Not only does that product get scrutinised and in the end, if successful certified. The entire design process must be documented and must also undergo the same level of certification as the end product itself.
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