To continue with the discussion about software validation in my three last posts, this is a new proof of the rising concept of software validation.

New section added about software

A quick diff on both versions of the guidance shows that there is news about software. They've created a new section about software: Medical devices that incorporate software and standalone medical device software.
This section contains two requirements.

PEMS left unchanged

The requirement about Programmable Electronic Medical Systems (PEMS) is left unchanged, except a word about standalone software.

Devices incorporating electronic programmable systems, including software, or standalone software that are devices in themselves, should be designed to ensure repeatability, reliability and performance according to the intended use. In the event of a single fault condition, appropriate means should be adopted to eliminate or reduce as far as reasonably practicable and appropriate consequent risks.

New requirement about software validation

They added a new requirement about software validation, that is in many ways similar to the one found in the proposal of new EC directive.

For devices which incorporate software or for standalone software that are devices in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, verification and validation.


IMHO, It's clear that software validation is becoming a hot subject!