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Qualification and validation

Safeguarded manufacture of medical industry products

GEMÜ performs a risk assessment for your product using the FMEA (Failure Mode and Effects Analysis) method and in accordance with the EN ISO 14971 standard. This includes investigating the system risks of the operating media and the process risks involved with manufacturing. We also provide you with information and recommendations with regard to potential design risks. These subjects are covered in the risk file for your project. This is continuously updated. At the same time, the measures defined in the file are monitored.

Four steps for qualifying operating media

Qualification enables GEMÜ to deliver documented proof that an operating medium satisfies the necessary requirements. 

Qualification comprises four stages:

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ) 
  • Performance Qualification (PQ)

The final qualification report documents observations, findings and any measures that are still outstanding. As a result, the design can be fixed and all production papers approved. At the same time, release is given for validation.

Process reliability through multiple validation runs

Validation provides the documented proof that the processes for manufacturing your medical industry product are safe and can be permanently guaranteed. For the process validation, the series product is manufactured in three separate batches. The batch size of the validation runs is determined by the desired quantities. If necessary, a larger test quantity can be agreed to analyze compliance with critical quality criteria. Following successful implementation, the qualification and validation phase is completed with a final report and, if required, an update of the FMEA.

GEMÜ can provide support for additional services to validate your product using its extensive partner network. This includes the following options:

  • Packaging validation
  • Transport validation
  • Ageing tests
  • Sterilization validation
  • Biological qualification

Basic standards for qualification and validation

  • EN ISO 13485
  • EN ISO 14971
  • MDR 2017/745 EEC
  • EU GMP guidelines