Medical devices that pass on the EMC and software side.

In medical technology it is not enough for a device to perform its function. Electronics and software must work reliably under defined conditions, be robust against interference and be developed and tested in a traceable way.

We support EMC questions, embedded software, electronics development and the technical verification of medical-related devices and systems. Clear interfaces, reproducible tests and clean technical documentation are particularly important here.

SAMD combines system-level development with an eye on EMC, testability and evidence. This means risks become visible not only before testing, but are addressed in a structured way already during development.

With medical devices, EMC requirements (IEC 60601-1-2) and the software life cycle (IEC 62304) come together — both risk-based and documented. We accompany both throughout development instead of testing at the end: planning, execution and documentation of verification tests and EMC tests, approval-compliant documentation, and the management of external development and manufacturing partners as well as test labs.

This also includes creating and revising requirement and test specifications for electronic assemblies and test setups — so that in the end all relevant normative and legal requirements are demonstrably met. (Check edition/standard revisions before use.)