Case Study: Fritz Stephan achieves enhanced collaboration, traceability, and regulatory compliance with Intland Software (codeBeamer ALM)

How an innovative medical device developer uses codeBeamer ALM to achieve compliance with minimal effort

Fritz Stephan GmbH is a German family‑owned medical technology company specializing in neonatal and pediatric ventilation, anesthesiology and oxygen-supply systems. Facing strict medical and avionics standards (IEC 62304, ISO 13485, DO‑160, ISO 14971) and developing safety‑critical devices, the team struggled with collaboration, change control and traceability while managing requirements in scattered Word/Excel files and homegrown tools.

To address this, Fritz Stephan adopted codeBeamer ALM (first licenses in 2014, scaled up by 2015) and rolled it out across development, QA, manufacturing and technical writing. The integrated ALM replaced fragmented document workflows with linked requirements, tests, issue tracking and risk management, enabling continuous compliance, simpler audits, faster change propagation and significant time savings in document generation—improving transparency, collaboration and time‑to‑market.

Fritz Stephan

Jens Amberg

Vice Chief Technology Officer