Case Study: Biosafe achieves FDA and IEC 62304 certification for Sepax cell separation system with Vector Software's VectorCAST/C++ test automation

FDA Compliance for Advanced Stem Cell Therapy

Biosafe SA, a Swiss medical technology company founded in 1997 and a leader in adult stem cell therapy and cell processing, needed to ensure their Sepax cell separation system met strict FDA and IEC 62304 software development requirements. Engineers faced the challenge of automating the core testing activities for the system’s embedded software to support regulatory certification.

To meet those requirements, Biosafe selected VectorCAST/C++ unit test automation tools running on Microsoft Windows Embedded platforms. By using VectorCAST, the Sepax development team automated critical embedded software testing and was able to achieve FDA and IEC 62304 certification for the Sepax system.

Biosafe