Software on Medical Devices is Governed by IEC 62304
IEC 62304 is a highly recommend standard by the FDA for medical device software development. As such it outlines, at a high level, a software development process driven by risk management for increased device safety.
The tricky part of it is that testing devices can be really complicated. There might be a whole ecosystem you need to standup just to test, and if the device is interacting with humans it’s trickier still. Parasoft Virtualize lets you quickly and easily stand up whatever test environment you need and perform end-to-end testing of a device in its environment – even if other pieces of the system aren’t available or aren’t finished yet.
Other Medical Software is Controlled by IEC 82304
IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
IEC 82304 governs the rest of medical software – in a nutshell, things that run on a general-purpose computer – like your PC. This covers things that run in the doctor’s office, online medical applications and the like. You want to make sure the software is accurate and reliable, and of course secure.