Case Study

Verification and Validation for Neonatal Ventilator Software

A well-known medical devices manufacturer approached Critical Software with the task of delivering verification and validation services for 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 verification and validations processes and developed the necessary evidence 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 techniques 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
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