EMKA Electronique: Certification of Safety-Critical Software for a New Medical Monitoring System

Since 1987, EMKA Electronique have used state-of-the-art industrial development tools enabling us to offer a full range of services, for example: studies, test benches, manufacturing, integration, reverse engineering, certification, etc. 
Our internal strategy is to provide internal training plans which enhance the skills and versatility of each employee, our teams adapt to all situations offering our customers the best solutions for their products. To this end, they can rely on modern development equipment and software continuously evaluated and renewed through our investment policy. 
In 2015 EMKA Electronique initiated a DDMRP strategy to implement an efficient supply chain. We maintain always up to date certifications for ISO 9001 (Industry and Services), ISO 13485 (medical), and EN 9100 (Aeronautics – Space – Defence).

One of our key customers in the Hospital/Medical supplies field asked us to develop a new connected, medical gas monitoring system. 
The system was to monitor multiple gases used in a hospital according to user threshold settings, additionally for defined changes in gas pressure it should trigger an alarm to notify field-based intervention teams to directly verify the status and immediately make any necessary repairs. 
The system was to be certified IEC 60601 and EN 62304 Medical Device class C; the risks associated with this need would require full code coverage and unit testing (which would take a significant amount of time and effort to achieve particularly if done by hand).