Case Study: Boston Scientific achieves FDA‑compliant embedded software testing for its COGNIS® CRT‑D with Vector Software's VectorCAST/C++

Embedded Testing with Patient Safety and Reliability in Mind

Boston Scientific needed to test and certify the embedded software in its COGNIS® CRT‑D to gain FDA approval. The COGNIS is a full‑featured, high‑energy cardiac resynchronization therapy defibrillator — among the world’s smallest and thinnest at 32.5 cc and under 10 mm — designed with patient safety, reliability and longevity in mind.

To meet FDA compliance the company used VectorCAST/C++ with MC/DC to automate testing and ensure repeatability, providing the rigorous, repeatable software verification required to support regulatory certification and maintain the device’s patient‑safety focus.

Boston Scientific