Support the development and updating of the design control processes, and of the parallel applicable processes and guidelines * Subject-specific involvement in the implementation of the risk management process, clinical evaluation, and usability file * Control and sole responsibility for reviewing/releasing approval-relevant documents as part of the design control process, in particular Risk analysis/risk management, clinical evaluation, design validation/design verification plans and protocols, software documentation, instructions for use and product labeling * Subject Mater Expert for the interpretation of standard requirements, e.g. for clinical evaluation, biocompatibility, electrical safety, cyber security etc. * Support of audits (customers/authorities and suppliers of medical devices) in coordination and cooperation with the QMR
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