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, connects R&D and quality management.
Compliance with ISO 14971
Orcanos software fully supports the risk-based approach that is crucial for A medical devices. The Orcanos IEC 62304 has a strong traceability to risk.
Risk work items are linked to requirements for mitigation, thus enabling companies to see a complete traceability matrix.
Based on the design input, you can add the design output artifacts, such as software requirements, hardware, and mechanical requirements.