Get 2 Documentation Toolkits for the price of 1
Limited-time offer – ends March 28, 2024

Expert Advice Community

Guest

Validation of equipment

  Quote
Guest
Guest user Created:   May 23, 2023 Last commented:   May 24, 2023

Validation of equipment

Hi, I was wondering if it is a requirement according to ISO 13485:2016 to use validated equipment during manufacturing and QC of IVDs

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 May 24, 2023

According to requirement 7.5.6 manufacturers must validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement. Furthermore, according to requirement 6.3 Infrastructuremanufacturer must document the requirements for the infrastructure needed to achieve conformity to product requirements. This definitively is considering using validated equipment during manufacturing.  

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

May 23, 2023

May 24, 2023