Medical Devices Directive 93/42/EC

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

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

Our Capabilities

  • 2007/47/EC Directive
  • Technical File
  • Product and design risk analyisis
  • Essential Requirements review
  • Product development

Key Skills

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

Experience

  • Risk Analysis (ISO 14971)
  • Medical devices development
  • From I to class III devices successfully submitted for CE mark