Proceedings from the Workshop on Science-Based Assessment Accelerating Product Development of Combination Medical Devices (2004) / Chapter Skim
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2 Science-Based Assessment and Experimental Design
2 Science-Based Assessment and Experimental Design
Pages 9-13
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From page 9... ...
A device is defined as an apparatus or implant intended for the diagnosis, mitigation, treatment, or prevention of disease that does not achieve its primary intended purposes through chemical action and that is not dependent on being metabolized. The review process for traditional devices, familiar to most device manufacturers, requires that a manufacturer demonstrate one of two sets of device classification criteria: · There must be reasonable assurance of the safety and effectiveness of the device based on preclinical and clinical evaluations; or · The device must have the same intended use as a predicate device, along with either the same technological characteristics or different technological characteristics that do not raise different questions of safety and effectiveness.
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From page 10... ...
In addition to testing the final product, safety testing and other assessments are performed throughout manufacturing in order to evaluate the manufacturing process itself and to ensure that the quality and consistency of the product lots are maintained. Standard test methods are of limited use, however, when testing biological products consisting of living cells.
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From page 11... ...
Outputs are measurable quantities that describe product characteristics or performance, such as the size of an extruded part or the yield of a chemical process. A mathematical understanding of how process inputs relate to outputs results in profound process knowledge and the power to control and improve processes.
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From page 12... ...
of the Department of Transportation is the agency with oversight responsibility for these certification processes; Boeing Commercial Airplanes interacts primarily with the FAA Aircraft Certification Service, Transport Airplane Directorate, Manufacturing Inspection Office, Seattle Aircraft Certification Office, and Seattle Manufacturing Inspection District Office. A designated engineering representative (DER)
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From page 13... ...
For Boeing structural certification, a building block approach is used, with testing on the coupon, element, detail, subcomponent, and component levels. For materials certification, efforts are currently being made to achieve faster qualification through the use of critical-chain project management and, to a limited extent, design of experiments.
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