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Integrate Design Control with Quality Management (QMS)
IEC 62304 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes.
Source: Medical device software — Software life cycle processes
Orcanos is an integrated system, connecting R&D and quality management.
Risk Management
Compliance with ISO 14971
Orcanos software fully supports the risk-based approach that is crucial for medical device. The Orcanos IEC 62304 has a strong traceability to risk.
Risk work items are linked to requirements for mitigation, thus enable companies to see a complete traceability matrix.
Design Input
Design Output
Based on the design input, you can add the design output artifacts, such as software requirements, hardware and mechanical requirements.
