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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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 24, 2023