Take the ISO 13485 course exam and get the ISO 9001 course exam for free
LIMITED-TIME OFFER – VALID UNTIL SEPTEMBER 30, 2021

Expert Advice Community

Guest

Can a medical device do self-calibration?

  Quote
Guest
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?

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
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:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Oct 15, 2020

Oct 16, 2020