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Quality & Documentation

Clean room facilities

Our dedicated employees are exclusively trained in clean room production and handling of products complying with DS/EN ISO 13485:2016 as well as specific customer quality requirements.


Quality control DS/EN ISO 13485:2016 >>



Computer control and monitoring ensure that all information is updated during production. Our tracing system is a part of an ERP system, Oracle, with an integrated quality module that will guarantee one hundred percent control.

Constant monitoring makes it possible to identify raw material batches. Throughout the production process relevant parameters are recorded and control measurements are made.

All Primo products are fully documented. Data sheets and approvals of the raw materials, technical data sheets, Certificates of Compliance or Certificates of Analyses are available and can be delivered by request.

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