Last time we opened our discussion on the Development stage of the systems engineering approach to medical device design and discovered that the best design concept is the one that meets all stakeholder requirements. Let’s use the flow chart shown in Figure 1 to illustrate what comes next in this stage.
Figure 1To begin the transformation from concept to completed design, engineers review documentation created during the Concept stage, including design notes, concept sketches, and of course the final requirements specification which has been approved by all stakeholders. Once the review is completed, it serves as a guide to the creation of detailed design documentation, including mechanical drawings, electrical schematics, and wiring diagrams. A bill of materials, or BOM, is also created, listing all parts needed to produce the final product. Each part designated within the BOM is associated with a specific manufacturer or supplying vendor, and each has been qualified with regard to price, availability, functionality, and quality. The design documentation and BOM are also subject to a review by a fresh set of eyes, engineers who have no involvement in the project. If they should discover a problem, the design is rejected and sent back to the design engineers for revision. This process of evaluation and correction are repeated until the design successfully passes a final review. Only then can the fully approved finished design move on to the production stage. Next time we’ll continue our discussion of the Development stage, moving our concept medical device further along its journey to the Production stage. ___________________________________________ |
Posts Tagged ‘design documentation’
Systems Engineering In Medical Device Design – Finished Design
Sunday, December 30th, 2012
Tags: bill of materials, BOM, concept stage, design documentation, design notes, design review, detailed design, detailed design documentation, Development Stage, electrical schematics, engineering expert witness, forensic engineer, functionality, manufacturer, mechanical drawings, medical device design, parts list, Production Stage, quality, requirements specification, supplying vendor, system stakeholder, systems engineering, systems engineering approach, wiring diagrams
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