Component Specifications for Medical Products

Project Managers:

Grace O'Malley, iNEMI

Peter Lampacher, MED-EL


The Component Specifications for Medical Products Project addressed the lack of industry-wide medical specifications for the qualification of components or their suppliers. This report summarizes the work conducted by this iNEMI project team to identify relevant critical components and then, using a case study of a specific critical component, to assess the level of understanding and technical knowledge needed to develop a relevant specification for that component that would be appropriate for medical devices.

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