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A System Design Review (SDR) is a scheduled review of many government-contractor relations, which ensures continuous involvement throughout a program. The SDR was originally defined in the Air Force's MIL-STD-1521.
Design review is also required of medical device developers as part of a system of design controls described in the US Food and Drug Administration's governing regulations in 21CFR820. In 21CFR820.3(h), design review is described as "documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design ...
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. [1]
The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...
The V-model is a graphical representation of a systems development lifecycle.It is used to produce rigorous development lifecycle models and project management models. The V-model falls into three broad categories, the German V-Modell, a general testing model, and the US government standard.
Configuration Identification (CI): consists of setting and maintaining baselines, which define the system or subsystem architecture, components, and any developments at any point in time. It is the basis by which changes to any part of a system are identified, documented, and later tracked through design, development, testing, and final delivery.
Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Requirements are defined, schedules are determined, and specifications are prepared to initiate system design and development." [32] In addition, as part of Phase B, the SIM Lite project was to go through a number of reviews by NASA including System Requirements Review, System Design Review, and Non-Advocate Review. [32]