Design Control
Manage the complete design and development lifecycle from user needs through design transfer. Maintain full traceability between design inputs, outputs, verification, and validation activities as required by FDA QMSR and ISO 13485.
Key Features
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Related Modules
Document Control
Manage the entire lifecycle of quality documents with version control, electronic signatures, and automated workflows. Ensure every SOP, work instruction, and form meets regulatory requirements with a fully auditable document management system built for medical device compliance.
Training Management
Ensure every team member is qualified and current on required procedures with automated training assignments and competency tracking. Maintain a complete training matrix that satisfies ISO 13485 competence requirements and FDA expectations.
Risk Management
Implement a complete ISO 14971-compliant risk management process from hazard identification through post-production monitoring. Maintain living risk management files with dynamic risk matrices and automatic residual risk recalculation.