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Like many of you, I have been slogging through the Practical Guide to ISO 13485:2016 since it came out end of September. To be honest I found it anything but practical. The guidance is a behemoth at 214 pages, contains circular references with vague language, and, even with its size, is not self contained, referencing additional guidances needed to fully understand recommendations. Here are some of the main reasons it does not deliver the clarity expected:
I discuss these points in detail in my latest blog. What were you expecting of the guide? What did you like or dislike? What was helpful to you?
The Practical Guide to the ISO 13485:2016 Practical Guide
Three things to consider before picking up the ISO 13485:2016 Practical Guide Manufacturers everywhere have been waiting a year and a half for additional guidance on the requirements of ISO 13485:2…
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