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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, connects R&D and quality management.


Risk 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.

Design Input

It starts with recording user requirements, which are then traced to the system or product requirements.

Design Output

Based on the design input, you can add the design output artifacts, such as software requirements, hardware, and mechanical requirements.

Verification and Validation

The test management module of Orcanos allows you to cover each design input artifact with a test case for validation, and cover each design output artifact with a test case for verification.

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