Case Study
Challenge, Approach, Outcome
1
Challenge
A class C IVDR medical device required a protective system that continuously monitors device behaviour and safely shuts the device down on misbehaviour — within strict functional safety requirements.
2
Approach
Development of safety-critical features in C on a custom real-time operating system: monitoring tasks, shutdown logic and patient alarms, verified with GoogleTest and hardware-in-the-loop testing against ISO 13485, ISO 14971, IEC 62304 and IEC 60601.
3
Outcome
The protective system monitors the device continuously, raises alarms on misbehaviour and initiates a safe shutdown — an integral part of the product's IVDR class C conformity.
Technology
Technologies Used
Details
Project Description
Develop safety critical features for a class C medical device. A protective system on the basis of a custom
real time operating system must monitor, shutdown the device and alarm the user in case of device misbehaviour.
This is done within context of functional safety requirements.
The project conforms to standards like ISO 13485, ISO 14971, IEC 62304, IEC 60601.