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Updating documentation
Hello, my company has medical device software and we have a lot of documents for our technical file. We updated a few documents from version 2 to version 2.1, new information was added, but a lot of documents don't have any changes (etc. we updated Clinical evaluation file, but we didn't changed System Architecture file). So my question is, should we update ALL technical file documents to V2.1, o should we change documents, which had changes - to v2.1 and other TF documents, which has no changes - leave v2.0?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Kristina Zvonar Brkić
Oct 15, 2019
No, you do not need to update all technical file documents to new version. You just mark changed documents to v 2.1, and the rest of the documents that did not change you can leave in version 2.0.
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Oct 14, 2019
Oct 15, 2019
Oct 15, 2019