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What form of signature does ISO 13485 accepts

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Guest user Created:   May 08, 2019 Last commented:   May 08, 2019

What form of signature does ISO 13485 accepts

The organization I work for is considering ISO 13485 certification in the future. Does ISO 13485 require hand written signatures or are electronic/digital signatures acceptable as long as we use a formal validation of the system for electronic signatures?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Verlene Law May 08, 2019

Answer:

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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May 08, 2019

May 08, 2019

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