ISO 13485 & EU MDR / Is special training necessary to get company certified to ISO 13485?
We are ISO 9001 certified company. I'm lead auditor certified. Do I need to take special training to get the company certified to ISO 13485?
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No, I do not think that you need special training. You have to study the ISO 13485:2016 requirements that differ from the ISO 9001:2015.
For start, I recommend you read the following article:
You can find a lot of articles in our ISO 13485:2016 Knowledge database and on ISO 13485:2016 Academy Blog.
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