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."
Clinet benefits
- Services from one single source from concept to qualification.
- Efficient risk management by specialists.
Client
Medical technology manufacturer, Ireland
