MDD 93/42/EC and MDR EU/2017/745

We help you demonstrate
that your medical device is compliant with the EU directive and with the new EU/2017/745.

Technical file of the product helps you to review your design and to safely applying the CE mark on your product.

Our Capabilities

  • MDR EU/2017/745
  • 2007/47/EC Directive
  • 93/42/EC Directive
  • Technical File
  • Product and design risk analyisis
  • Essential Requirements review
  • Software validation
  • Product development

Key Skills

  • 10+ years experience
  • Knowledge transfer
  • ISO 14971 approach
  • Integration with your quality management system (QMS)
  • Design for manufacturing approach
  • Product Labeling

Experience

  • Risk Analysis (ISO 14971)
  • Medical device development
  • Devices from class I to III successfully submitted for CE mark