sepp.med stands for many years of expertise in the development and assurance of software for medical technology and digital health. The company supports manufacturers and suppliers throughout the entire lifecycle—from requirements and architecture through implementation and integration to verification/validation and release. Focus areas include safety, security, and compliance (e.g., IEC 62304, ISO 14971, IEC 82304-1, IEC 62366-1, ISO 13485). Where appropriate, data-driven, AI-assisted methods are used in development and quality assurance—validatable, traceable, and embedded within regulatory frameworks.
Services from a single source:
- Consulting: Process and quality consulting, regulatory affairs, risk and usability engineering, cybersecurity; establishing audit‑proof development processes and evidence.
- Engineering: Development of software solutions up to Software as a Medical Device (SaMD), integration & testing, test automation, continuous compliance, and assurance of networked systems; methods for automated test design and prioritization.
- Academy: Practice-oriented seminars and trainings on quality, testing, safety/security, and regulatory requirements.
Product/Tooling:
With the MBTsuite, sepp.med offers a platform for model-based testing (MBT) that enables the automatic generation of executable test cases and supports teams with traceability, collaboration, efficiency, and standards‑compliant documentation.
sepp.med is an owner-managed, medium-sized company headquartered in Röttenbach near Erlangen. The goal is to lead medical technology projects to success efficiently, in conformity with standards, and in a future‑proof way—from start-ups to large enterprises.