Case Study: Worldwide Infusion Pumps Manufacturing Company achieves IEC 60601 alarm compliance with Auriga

Worldwide Infusion Pumps Manufacturing Company - Customer Case Study

Worldwide Infusion Pumps Manufacturing Company hired Auriga to ensure the compliance of its infusion pump alarm subsystem with the 3rd edition of IEC 60601-1-8, addressing the challenge of achieving basic safety for the device’s alarm system. The work focused on embedded software in C++ using Microsoft Visual Studio.

Auriga delivered a full compliance effort using an agile model with weekly sprints, direct communications, and joint reviews. The team specified, tested, and documented 200 alarm behavior patterns, developed and executed manual and automated tests, performed both white-box and black-box testing, and produced the required documentation, helping accelerate project performance and meet internal standards.