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