Medical devices come in all shapes and sizes, and a great deal of them contain – or consist of – software. If they are faulty, they can kill. We’ll talk about different types and classes of medical devices, the regulations that try to ensure their safety and what all of this means for medical software projects.
So you have a great idea for a medical product with software that will make the world a better place? It helps people to regain or improve their health, cope with a permanent condition or analyze their vital stats? That’s fantastic! What could possibly go wrong?
History has shown that faults in medical devices can have disastrous consequences. Those products may cause severe injury, permanent damage, even death. In order to make sure that your product does not harm its users there is a bunch of regulations that you have to comply with. How does this affect your work?
First we’ll take a look at where to find software in or around medical devices from embedded code to stand-alone sofware with AI. Then I’ll provide a few infamous examples of what went wrong (including a great talk about faulty software in pacemakers from CCC Camp 2019 – you know, that last great event before THE VIRUS).
Then we’ll talk about the regulatory part, especially at the EU Medical Device Regulation and what it means for planning, implementing and maintaining software for medical products (my favourite topic: traceability. ;-) ). It’s also of interest for non-EU participants because many of the regulations are ISO-harmonized.