Guest user Created: Oct 15, 2020 Last commented: Oct 16, 2020

Can a medical device do self-calibration?

Can a medical device do self-calibration or does it need another calibrating device to do the calibration?

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Kristina Zvonar Brkić Oct 16, 2020

Yes, a medical device can do self-calibration, but this performance must be validated. Also, if it is applicable, self-calibration has to be explained in the instruction of use.

For more information regarding the validation and calibration, please see the following articles:

Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
Calibration requirements in ISO 13485 https://advisera.com/13485academy/blog/2019/03/08/calibration-requirements-in-iso-13485/

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Oct 15, 2020

Oct 16, 2020

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