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Workbook - 27Sep01 -v2
https://www-edc.eng.cam.ac.uk/sites/www-edc.eng.cam.ac.uk/files/gooddesignpractice1_0.pdf21 Oct 2022: THE AUTHORS. Dr Karen Alexander is a Change Control Manager atthe Wound Management Division of Smith & NephewMedical Limited. This workbook is based on her PhDthesis 'Design for Validation of Medical Devices andEquipment', published in August 1999. -
verification workbook2h7-arf - 06Nov02
https://www-edc.eng.cam.ac.uk/sites/www-edc.eng.cam.ac.uk/files/gooddesignpractice3_0.pdf21 Oct 2022: FDA (1996), 21 Code of Federal Regulations, Parts 808, 812, and 820, Medical Devices…, p52620).
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