The 37Company needed to upgrade their product, the Fluido®Compact, with a redundant safety system for compliancy reasons. The embedded software for the Fluido Compact is classified as Class C (‘Death or serious injury is possible’) in the IEC 62304:2006. The system’s main safety hazard is the fact that the temperature of the fluid it contains can become too high. As such, a parallel and dedicated Safety Controller circuit is needed for independent Non-Self-Resetting Thermal Cut-Out.
Sioux redesigned and expanded upon the existing code, built the test environment and supported the integration of this device into the system. The most important challenge during this project was the verifiable proof of quality. As such, development was carried out in accordance with ISO 13485. Compliance is ensured by way of the introduction of a strict code reviewing process and the traceability of reviews across Mantis and Subversion. Our second contribution was the 1-to-1 tracing between requirements and mostly automated tests. The automated tests, written in SpecFlow, function as a black box for the Safety Controller. Sioux delivered a validated safety control device for the Fluido®Compact product, ready to be validated by UL and Dekra.
The 37Company is able to deliver a compliant and safe product and is therefore successful in business in the USA and Europe.
C running on STM32F0 Microcontroller, SpecFlow using Nunit and C#, and Omega DAQ generating analogue.
The 37Company distributes, develops and manufactures a range of specialty medical devices and supplies for healthcare professionals. The products primarily focus on patient temperature management.