ISO 13485 & EU MDR / 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?
Please select user.
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, clinical chemistry reagents are considered to be in vitro diagnostic medical devices, therefore ISO 13485:2016 is apllicable as quality management standard.
HTML tags are not allowed