Jul 05, 2021
Jul 12, 2021
Expanding and elaborating scope
My question is
1- I am going to Update the medical device file as per Eumdr (Article 1) so what should be the scope? As per my understanding, I have defined the scope for PACS
This procedure applies to:
Technical/engineering documentation required for the release of XYZ medical device software.
Changes to the product, process, facility, quality system, or organization.
All countries and territories where XYZ medical devices are approved for sale (EU for CE Marking)
Just want to confirm is this sufficient scope or should expand our scope or if you suggest some more.
2- What is the new changes as per new ISO 15223-1:2021 for PACS software
3- Is there any specific retention time period for software? As per MDR 10 years after the last device covered by EU DOC & for implantable for 15 years.
Assign topic to the user
Please select user.