Case Study

V&V for Neonatal Ventilator Software

A well-known medical devices manufacturer approached Critical Software with the task of performing verification and validation activities on complex software used by their new neo-natal ventilators. The system required certification as a Class C device according to IEC 62304, an EU standard defining the lifecycle requirements for medical device software.

Critical Software’s solution provided detailed and complete analysis of all the V&V processes and developed the necessary evidences to comply with IEC 62304. A test environment was also created to enable test automation and automatic regression testing.

In this case study, find out more about:
  • What V&V activities this project involved
  • Our engineers’ approach to tackling challenges during the project 
  • The results delivered to our client because of our approach
  • How our efforts ensured a full certification for the neonatal ventilators that are now used worldwide