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Thursday, August 26, 2004 - 4:10 PM
SES 7B.3

Managing Materials Information for Medical Devices

D. Cebon, Granta Design Ltd., Cambridge, United Kingdom

The materials information management needs of the medical device design sector are considered, with reference to the three main information handling phases: ‘consolidation’ (management of raw test data), ‘analysis’ (investigation of material trade-offs) and ‘dissemination' (secure distribution of data throughout an organization). The specific requirements for quality control, traceability, handling of pedigree information, controlled access to secure data, standards and FDA approvals are discussed. An information architecture that attempts to satisfy the complex requirements of the medical devices industry is discussed and a case studies is presented.