left-svg
Bonus expert support worth $500
with the ISO 13458 Documentation Toolkit
Limited-time offer – ends June 30, 2022.
right-svg

Expert Advice Community

Guest

Implementation ISO 13485 on making medical materials for medical laboratories

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

Implementation ISO 13485 on making medical materials for medical laboratories

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

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 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

Sep 01, 2021

Sep 01, 2021