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A design review provides an in-depth assessment by an independent team of discipline experts and managers that the design (or concept) is realistic and attainable from a programmatic and technical sense. Design review is also required of medical device developers as part of a system of design controls described in the US Food and Drug ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
In general, a checklist is a quality management tool, an aid to completing a complex task correctly and completely. It is an aid to recall, provides a reminder of the correct sequence, and uses the operator's knowledge and skill efficiently to ensure that no critical steps are omitted, even when the operator is under stress or has degraded attention due to fatigue or other distractions, It ...
The most recent version of the Statement—the CONSORT 2010 Statement—consists of a 25-item checklist and a participant flow diagram, along with some brief descriptive text. The checklist items focus on reporting how the trial was designed, analyzed, and interpreted; the flow diagram displays the progress of all participants through the trial.
Design review. 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 ultimate design review, if successful, therefore ...
Advanced product quality planning. Advanced product quality planning ( APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation, but has similarities to Design for Six Sigma (DFSS).
Commissioning (construction) In construction, commissioning or commissioning process (often abbreviated Cx) [ 1][ 2][ 3] is an integrated, systematic process to ensure, that all building systems perform interactively according to the "Design Intent", through documented verification. The commissioning process establishes and documents the "Owner ...
Design for manufacturability (also sometimes known as design for manufacturing or DFM) is the general engineering practice of designing products in such a way that they are easy to manufacture. The concept exists in almost all engineering disciplines, but the implementation differs widely depending on the manufacturing technology.