Expert Advice Community

Home / ISO 13485 & EU MDR / Implementation ISO 13485 on making medical materials for medical laboratories

Guest

Implementation ISO 13485 on making medical materials for medical laboratories

ISO 13485 & EU MDR

Quote

Guest

Guest user Created: Sep 01, 2021 Last commented: Sep 01, 2021

Implementation ISO 13485 on making medical materials for medical laboratories

ISO 13485 & EU MDR

For the ISO 13485, I know it is applicable for the manufacturing of clinical chemistry reagents since it is used for the diagnostics tests, is it correct?

0 0

Assign topic to the user

Select user

Expert

Kristina Zvonar Brkić Sep 01, 2021

Yes, clinical chemistry reagents are considered to be in vitro diagnostic medical devices, therefore ISO 13485:2016 is apllicable as quality management standard.

Quote

0 1

Comment as guest or Sign in

HTML tags are not allowed

Name *

Email *

I accept the Privacy and Terms

Notify me when someone replies

Sep 01, 2021