Technical Documentation FAQ
Are there any guidelines for the structure of the Technical Documentation?
What should be in each section? What do Notified Bodies expect to see?
We have all the answers…
technical file
EU MDR how to structure your Medical Device Technical Document
The device’s design, intended use claims, composition, and clinical studies are all covered in great depth in the Technical Document. It serves as a device’s “everything you must know” manual, so CLIN-r+ looks at what it entails.
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