IEC 62304 Compliance Software

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

Integrated Quality Management (QMS) and Design Control

Orcanos is an integrated system, connecting R&D and quality management.

This chart illustrates the following use case:

In this use case, we see that a complaint derived a risk, and the risk mitigation is by design, so we have linked a requirement to the risk, and test case to the requirement.

When we talk about a complete development lifecycle, especially with software, the traceability becomes a major part of the process, as traceability connects all SDLC (Software Development Lifecycle) parts together

Taking this illustraiton and focus on the IEC 62304 compliance, we can see the following example:

Orcanos connects all SDLC artifacts, in order to comply with the IEC 62304. If you are using 3rd party tools such as Jira for developes, or Jenkins for CI/CD, you can easily integrate them into the regualted process Orcanos is supporting.

Design Input

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

Design Output

Based o nthe design input, you can add the design output artifcts, such as software requiremetns, 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.

Risk Management, ISO 14971 Compliance

The Orcanos IEC 62304 has a strong traceability to risk.

Risk work items are linked to requirements for mitigation, ths enable companies to see a complete traceability matrix, as below: