ISO 13485 & EU MDR / 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?
Please select user.
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
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:
HTML tags are not allowed