A design review is a milestone within a product development process whereby a design is evaluated against its requirements in order to verify the outcomes of previous activities and identify issues before committing to—and, if need be, to re-prioritise—further work. The ultimate design review, if successful, therefore triggers the product launch or product release.
5-410: The conduct of design reviews is compulsory as part of design controls , when developing products in certain regulated contexts such as medical devices . By definition, a review must include persons who are external to the design team. In order to evaluate a design against its requirements, a number of means may be considered, such as: Most formalised systems engineering processes recognise that
10-545: The Food and Drug Administration (FDA) has required that medical device manufacturers that want to market certain categories of medical devices in the USA follow Design Control requirements (21 CFR 820.30). At a high level, this regulation requires: The Medical Devices Directive (MDD 93/42/EEC) similarly lists several requirements regarding the design of a medical device. The Medical Devices Regulation (MDR (EU) 2017/745), replacing
15-490: The MDD from 2021, requires information to allow the design stages applied to the device to be understood as part of the design and manufacturing information of a technical documentation for a medical device. ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and
20-490: The cost of correcting a fault increases as it progresses through the development process . Additional effort spent in the early stages of development to discover and correct errors is therefore likely to be worthwhile. Design reviews are example of such an effort. Therefore, a number of design reviews may be carried out, for example to evaluate the design against different sets of criteria (consistency, usability , ease of localisation , environmental) or during various stages of
25-438: The design process. This engineering-related article is a stub . You can help Misplaced Pages by expanding it . Design controls Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory (by regulation) to implement such practice when designing and developing products within regulated industries (e.g. medical devices ). Since 1990,
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