Case Study: Inomed achieves streamlined IEC 62304 certification with Parasoft Development Testing Platform

Inomed Streamlines IEC 62304 Medical Device Software Certification

Inomed, an international medical-technology company specializing in intraoperative neuromonitoring and nerve-protection systems, faced the critical challenge of proving and sustaining IEC 62304 compliance for software where failures can directly endanger patients. Their initial certification processes were largely manual and paper-based, so they sought to automate risk management, enforce coding standards, and reduce the effort required to certify emerging products.

Inomed adopted the Parasoft Development Testing Platform, which integrated with their heterogeneous toolchain (C++, .NET, Visual Studio, Keil, Bugzilla, CVS) and was deployed via a preconfigured VM, enabling fast rollout. The platform automated static analysis, unit testing, and bidirectional requirements traceability, markedly reducing manual work, increasing efficiency, and providing the audit-ready traceability that helped DQS certify their process to IEC 62304.

inomed

Jörg Wipfler

Head of Development