FDA Compliance for Advanced Stem Cell Therapy
Challenge: 

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.

Solution: 

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.

Details: 

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.

Biosafe
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