FDA Compliance for Advanced Stem Cell Therapy

In order to meet FDA and IEC 62304 software development requirements on their Sepax cell separation system, engineers at Biosafe needed a solution that would allow them to automate much of the key activities associated with the testing of its embedded software.


To build the Sepax cell separation system and meet FDA and IEC 62304 certification, Biosafe selected VectorCAST/C++ unit test automation tools with Microsoft Windows Embedded Platforms.


Established in 1997, Biosafe SA is a global medical technology company with headquartered Switzerland and has become the industry standard in the field of adult stem cell therapy and cell processing solutions. Biosafe engineers use VectorCAST/C++ with Microsoft Windows Embedded Platforms to build the Sepax cell separation system. Using VectorCAST, Biosafe's Sepax development team was able meet FDA and IEC 62304 certification.

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