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Validation of equipment

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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

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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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.  

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May 23, 2023

May 24, 2023