SaMD under IEC 62304: medical software with a controlled lifecycle.

We implement the medical device software lifecycle under IEC 62304, from safety classification (A, B, C) to architecture, verification, SOUP management and maintenance processes - the engineering foundation behind SaMD registration.

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SaMD under IEC 62304: medical software with a controlled lifecycle.
What we deliver

We structure your software process to produce the evidence regulators require.

  1. Software safety classification (Class A, B or C).

  2. Lifecycle planning and software requirements.

  3. Architecture, detailed design and requirements traceability.

  4. Verification, testing and SOUP management (third-party software).

  5. Maintenance, problem management and change management processes.

Deliverables

What you receive

A software lifecycle plan and safety classification.
A requirements specification and architecture document.
A traceability matrix and verification reports.
A SOUP register and software maintenance plan.
References

Reference standards

  • IEC 62304 - medical device software lifecycle processes.
  • ISO 14971 and IEC 62366-1 - risk and usability integrated into software.
  • Complements ANVISA SaMD market authorisation (see the corresponding service).
FAQ

Frequently asked questions

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Does your medical software have a lifecycle documented under IEC 62304?

We implement the process from the ground up to an auditable state.

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