SOP related to IFU
In the toolkit was not included any SOP related to the control of labels and IFU’s of medical devices.
As it is obvious to us that we need such an SOP, could you provide me with a template of the procedure and the relative form?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
You are right, there is no procedure for translation labels and instruction of use. We concentrated on this toolkit on documentation related to ISO 13485 and documented requirements from MDR. Nowhere in the MDR is it stated that it is necessary to document the translation procedure. Your labels and Instruction for use must have proper symbols according to harmonized standards, and you need to ensure that translation is correct and professional. Usually, medical device manufacturers use certified translation companies for this.
For more details on mandatory documentation from MDR, please see the following white paper:
- EU MDR Checklist of Mandatory Documents: https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents
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May 19, 2020