Our registrar auditor casually mentioned that performing software updates to medical devices in the field is considered installation. We currently have scoped out installation from our ISO 13485:2016/MDSAP certificate, but plan to launch a medical device soon that will have software and want to plan for inevitable updates.
Can anyone confirm or reject the auditor's assertion? Do we need to expand our scope?
Thanks!
Can anyone confirm or reject the auditor's assertion? Do we need to expand our scope?
Thanks!