Case Study: ActiGraph achieves FDA & IEC 62304 compliance with Vector Software's VectorCAST test automation

IEC 62304 and FDA Complaince for ActiGraph Wearable Devices

ActiGraph, a provider of validated wearable hardware and software used by scientific, academic, and pharmaceutical organizations, needed to meet FDA and IEC 62304 software development requirements for its latest activity monitoring devices. The software team’s primary challenge was automating the key testing activities for embedded software to support regulatory compliance.

Following an evaluation, ActiGraph selected the VectorCAST test automation platform for its advanced functionality and IEC 62304 certification. VectorCAST enabled automated unit, integration, and system testing along with code coverage analysis, requirements traceability, and on‑target testing, simplifying validation workflows and helping ActiGraph achieve the testing rigor required for FDA and IEC 62304 compliance.

ActiGraph