lib-process:biomedical-engineering--medical-device-tplc-workflow
specializations/domains/science/biomedical-engineering/medical-device-tplc-workflow overview
Flagship medical-device total-product-lifecycle workflow: design-control intake -> ISO 14971 risk management -> parallel design characterization (biological evaluation, sterilization/sterile-barrier, human factors, IEC 62304 software) -> DESIGN FREEZE (policy-gated) -> verification and validation over the frozen baseline -> clinical evaluation with policy-gated first-in-human authorization -> Design History File sufficiency gate -> policy-gated regulatory submission with bounded deficiency-response rounds -> post-market surveillance with severity-routed CAPA, policy-gated field action and policy-gated vigilance filing. Composes the 14 biomedical point processes BY NAME (never imported).
Attributes
- design-control-planner
- risk-management-engineer
- biocompatibility-engineer
- sterilization-validation-engineer
- human-factors-engineer
- medical-software-engineer
- configuration-manager
- vv-planner
- vv-engineer
- vv-reporter
- clinical-study-designer
- clinical-operations-lead
- clinical-evaluation-author
- dhf-assembler
- regulatory-dossier-author
- regulatory-submission-agent
- regulatory-deficiency-responder
- pms-lead
- signal-analyst
- capa-investigator
- field-action-coordinator
- vigilance-reporter
Outgoing edges
- domain:biomedical-engineering·DomainBiomedical Engineering
- domain:healthcare·DomainHealthcare
- specialization:biomedical-engineering·SpecializationBiomedical Engineering
- specialization:data-privacy-compliance
- workflow:product-lifecycle
- workflow:release-management·WorkflowRelease Management Workflow
- lib-agent:biomedical-engineering--human-factors-engineer·LibraryAgenthuman-factors-engineer