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Electronic signature for ISO 13485 documentation
Can you provide guidance on electronic signatures? Is there any special requirements or can we use a simple adobe sign for signing off on procedures etc for compliance?
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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
Expert
Kristina Zvonar Brkić
Jun 25, 2019
Answer:
Simple Adobe sign is enough. ISO 13485 does not dictate the form of signature used. Companies can use electronic documents even without digital signature, it is sufficient to prove that the authorized person has approved them through email or document management system.
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Jun 25, 2019
Jun 25, 2019
Jun 25, 2019