01. THE CHALLENGE
Verification and validation are universal challenges for medical device manufacturers. However, some organizations are unable to perform these activities at the level required to achieve product certification - particularly when software is involved.
A global leader in medical technology was developing a product designed to support surgical stapling, incorporating features such as real-time control over the stapling of different types of human tissue. The software component required specialized and independent certification that could not be addressed by internal V&V capabilities. As a result, the company partnered with Critical Software to bridge this gap.
02. THE SOLUTION
In preparation for testing, Critical Software defined a verification strategy in compliance with EU and FDA regulations governing software safety classification in medical devices.
An automated testing environment was developed for the code, ensuring the surgical stapler could operate reliably under all conditions. Using VectorCast—a user-friendly software testing tool specified by the client—we ensured maximum traceability and coverage when implementing Software Validation Test Procedures (SVTP).
These procedures were then delivered to the client. In addition to describing the developed test processes, they detailed how each procedure contributed to full requirements traceability.
Finally, comprehensive test reports were produced to support the certification process.
03. THE RESULTS
The test specifications and procedures established by Critical Software enabled early detection of several defects in the surgical stapling software, significantly reducing overall development costs.
This process included introducing new algorithms and refining existing ones within the manufacturer’s codebase, as well as producing detailed documentation to demonstrate compliance with EU and FDA standards.
Combined with highly flexible and rapid testing procedures, Critical Software’s support enabled full product certification within a short timeframe—allowing the manufacturer to accelerate time-to-market.
04. THE TECHNOLOGY
VectorCast
Test automation
Test specifications and reporting
Certification based on EU and FDA regulatory compliance