Machinery Directive 2006/42/EC

We help you demonstrate
that your equipment is compliant with the EU directive.

Technical file of the equipment helps you to review your design and build safe machinery, applying the CE mark.

Our Capabilities

  • 2006/42/EC Directive
  • Technical File
  • Safety Essential Requirements review
  • Risk Analysis of the Machine
  • PL Calculation (ISO 13849)
  • User and Maintenance manual
  • Design development and review for safety

Key Skills

  • 10+ years experience
  • Translations in Italian, English, Spanish and French
  • Integration with your quality management system (QMS)
  • InDesign user manual templates
  • Analysis and review of the safety features of the machine
  • Spare parts list development
  • Integration with process validation

Experience

  • Machines for medical processes
  • Packaging machines
  • Pharmaceutical automations
  • Cosmetics automations
  • Food automations
  • Automotive
  • Custom automations