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The ultimate design review, if successful, therefore triggers the product launch or product release. 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.
The PDR demonstrates that the preliminary design meets all system requirements with acceptable risk and within the cost and schedule constraints and establishes the basis for proceeding with detailed design. It will show that the correct design options have been selected, interfaces have been identified, and verification methods have been ...
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The SDR is a technical review conducted to evaluate the manner in which a project's system requirements have been allocated to configuration items, manufacturing considerations, next phase planning, production plans, and the engineering process that produced the allocation. This review is conducted when the system definition is at a point where ...
Preliminary Design Review, a step in the engineering design process; Purchase of development rights — see Conservation easement; Petition for Discretionary Review - In appellate law, a way of seeking review by a higher court when no appeal of right exists
An independent reviewer is an individual who does not have direct professional responsibility for the design stage under review, assuring an independent and objective review. Within the context of formal design reviews, the practical solution is simply to ensure a fresh perspective, based on the principle that those who are too close to the ...
A simple element of risk quantification is often introduced in the form of a risk matrix, as in preliminary hazard analysis (PreHA). The selection of the methodology to be used depends on a number of factors, including the complexity of the process, the length of time a process has been in operation and if a PHA has been conducted on the ...
Design review; Design transfer ensuring that the device design is correctly translated into production specifications; Design changes; Design history file, a demonstration that the design was developed according to the approved design plan and 21 CFR 820.30.