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Expanding and elaborating scope

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Guest user Created:   Jul 05, 2021 Last commented:   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.
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 12, 2021
My question is 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.

If this scope is enough to completely describe your product and if the purpose of the product is clearly seen within that scope, then it is enough.

What is the new changes as per new ISO 15223-1:2021 for PACS software

Yes, there is a special symbol for software. And also there is a symbol pointing to a website with additional installation instructions (if you have one). 

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 .

So far there is no specific retention time period for software. However, be aware that you need to follow additional information from the MDCG group. They regularly publish new guidelines and interpretations: https://ec.europa.eu/health/md_sector/new_regulations/guidance_hr

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Jul 05, 2021

Jul 12, 2021