We develop software for regulated markets in a structured, compliant, and efficient manner. At Sepp.Med, we combine software development with agile systems engineering, DevOps, CI/CD, and rigorous quality assurance. We work in the automotive, medtech, and e-government sectors. Our teams deliver traceable artifacts, seamless traceability, and audit-ready documentation from requirements through architecture, implementation, verification, validation, and maintenance.
Thanks to our deep industry expertise, we comply with relevant standards and norms, including IEC 62304, ISO 13485/14971, Automotive SPICE (ASPICE), ISO 26262, and ISO/IEC 27001. Modern toolchains, test automation, AI-assisted code reviews, and metrics (e.g., lead time, deployment frequency, defect escape rate) ensure predictable quality and a short time to value. The result is scalable, maintainable software products that combine security, compliance, and market readiness.
Would you like to start or modernize a project? We can handle the entire process from start to finish, work alongside your team in co-development, or provide targeted experts—all transparently, efficiently, and measurably.
We invite you to the next edition of the Afterwork Exchange. On September 24, 2026, decision-makers and experts will come together to discuss current trends in AI and software development. Join us for the discussion!
Software engineering is the holistic, methodical framework (e.g., requirements management, architecture, quality assurance). Software development is the operational implementation. We combine both to deliver products that comply with standards and are easy to maintain.
Depending on the industry, these include IEC 62304, ISO 13485 and ISO 14971 (MedTech), Automotive SPICE and ISO 26262 (Automotive), as well as ISO/IEC 27001 for information security. We provide the necessary evidence and documentation.
Scoping & Kick-off → Requirements/Backlog → Architecture & Design → Iterative Implementation → Verification/Validation → Release & Maintenance. With clear quality gates, definitions of “Ready” and “Done,” and seamless traceability.
AI-powered tools now support key tasks in software development: automated code reviews, test case generation, and requirements analysis. sepp.med integrates these technologies where they measurably shorten the development cycle and ensures that their use remains validated and audit-ready even in regulated environments. Learn more at AI Consulting.
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