Reference project

Preparation of an EU Declaration of Conformity for a test station

EXCO is contracted with the testing of the production safety and certificate the EU conformity declaration.

  • Qualification (IQ, OQ, SAT, FAT, validation report, risk analysis)
  • Create a test report of compliance to guidelines of product safety
    • Operation instructions in English compliant to DIN EN ISO 82079-1
    • Risk assessment according to machinery directive 2006/42/EC
    • Risk evaluation
    • Inspection of safety precautions
    • Research of regulations and safety standards
    • Compilation of the complete technical documentation
    • Specification of compliance (RoHS, MRL, NSP, EMC) for supplier parts
    • Review of the technical documentation
    • Issuing of an EU declaration of conformity

EXCO combines development expertise with know-how in the area of product safety, qualification and validation.

Stephan Blab, Corporate Strategy, EXCO Gm

Clinet benefits
  • Services from one single source from concept to qualification.
  • Efficient risk management by specialists.


Medical technology manufacturer, Ireland

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