23
Nov
2020

ISO 14971 Updated in 2019 Release

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ISO 14971 was updated and released in 2019.  We previously discussed the internal debate regarding ISO 14917 in this post ISO 14971 versus the EU Commission.

There are several items to consider with the new update:

  1. Section 10.1 - “The manufacturer shall establish, document and maintain a system . . .

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About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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