Legacy software

The 2015 amendment added a route for legacy software: assess the post-production data and risks, identify the gaps, and close the ones that matter for safety instead of redoing the whole development.

MEDICAL DEVICE SOFTWARE which was legally placed on the market and is still marketed today but for which there is insufficient objective evidence that it was developed in compliance with the current version of this standard

IEC 62304:2006+AMD1:2015, clause 3.36