Your auditor assesses your quality system, and our work runs inside it. You control Silurus Software as a supplier under ISO 13485 clause 7.4. Our IEC 62304 lifecycle work runs inside your ISO 13485 QMS, and our regulatory specialists and FDA consultants advise on that system as a service of its own.
Silurus Software engineers work under the client's procedures, in the client's templates and tools, and through the client's review workflow. Each document we write is reviewed and approved in the client's document control, and the ones the client's procedures name enter the design and development file and the technical documentation.
The work products are software development plans, software requirements, architecture and detailed design, software risk analysis, verification protocols and reports, traceability matrices, SOUP records, SBOM and threat models. They are written to the client's procedures and go through the client's review before they enter the file.