01. THE CHALLENGE
In the medical device industry, ensuring that equipment functions correctly is critical.
A leading manufacturer of neonatal ventilators was developing new equipment that required complex software, which also needed certification as a Class C device under IEC 62304—an EU standard that defines lifecycle requirements for medical device software.
As is typical in certification processes, the manufacturer required an independent assessment of the software to ensure its safety and suitability for use with newborns.
02. THE SOLUTION
Critical Software conducted a comprehensive analysis of all verification and validation (V&V) processes to support the complex software certification required for the ventilator.
All activities and supporting evidence were developed in compliance with IEC 62304, which governs software lifecycle requirements in the EU. This standard provided a structured framework for the medical device software lifecycle processes applied throughout the project.
The engineering team created a dedicated test environment to ensure compliance with Class C software requirements. This environment enabled both automated testing and continuous regression testing.
The development of detailed test specifications and procedures—including test case execution and in-depth analysis of results—was essential to ensuring that all manufacturer requirements were met.
03. THE RESULTS
With a flexible and highly skilled team, Critical Software delivered full V&V support capable of accommodating late-stage requirement changes and defect corrections.
The team provided an independent assessment of all critical control functions, while generating the necessary evidence to support risk mitigation.
As a result, the neonatal ventilator software achieved full certification and is now in use across hospitals and clinics worldwide.
04. THE ACTIVITIES
Verification & validation
Documentation for IEC 62304 compliance
Automated testing environment
Risk mitigation