Lunchlezing Sioux

When Software Gets Serious

Risk management in medical applications

Software is everywhere, and this is also true in healthcare. Things like patient records, doctor’s appointments and medication prescriptions are all managed electronically through software, and almost all modern medical devices are controlled by software. Bugs in this software can have annoying consequences (an appointment is delayed) but can also lead to catastrophic outcomes, like the immediate death of a patient.

This puts a heavy responsibility on the shoulders of everybody who is involved in the software development process. Given the fact it seems impossible to prove in advance a piece of software is 100% correct, how do we minimize the potential harm caused by our software?

Using a newly developed and recently CE certified medical device as an example, Sioux software architect Jeroen Bouwens will demonstrate how risks can be managed. He will show elements like risk analysis, mitigating design elements and risk priority numbers and how such concepts are applied in practice.