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

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

Medical technology manufacturer, Ireland