Hemoglobin assay for validation and quality control of medical device reprocessing

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A successful "medical device" development requires the collaboration be-tween designers, developers, and quality engineers to be able to assess needs, functional requirements, specifications, and problems at every stage of development. The quality control of the developing process is achieved through a predefined set of policies, quality assessment, and the management of activities to eliminate defects and weaknesses wherever the development process.


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