ISO 13485 & EU MDR / New requirements for technical files
We are working through our documentation with the help of Advisera. I do have questions on the new requirements for technical files. Do you have any samples or templates available?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
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You have a template for technical documentation in the folder Technical file. The name of the document is the Technical file template.
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