Reference project

EU conformity declaration for a test station

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


Realization
  • 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, Head of Competence Center Process Qualification, EXCO GmbH
Clinet benefits
  • Services from one single source from concept to qualification.
  • Efficient risk management by specialists.

Client

Medical technology manufacturer, Ireland

Expert contact

Stephan Blab

T+49 6233 73778-120