Robust designfor compliant products

We help you demonstrate that your medical deviceis compliant with MDR EU/2017/745and is able to get European market access.

Technical documentation serves to prove that a medical device meetsthe general safety and performance requirements and should be prepared in a clear, organised, readily searchable and unambiguous manner.

Our capabilities

  • MDR EU/2017/745 (and previous directives)
  • ISO 13485:2016
  • Support in medical device technical documentation submission to Notified Bodies
  • Benefit-risk analysis and risk management (ISO 14971)
  • General Safety and Performance
  • Requirements review
  • Sample size procedure for product V&V testing
  • Product labelling (ISO 15223)
  • Design for manufacturing approach
  • QMS procedures
  • Regulatory Affairs consulting
  • FDA remediation
  • Integration with customer quality
  • management system (QMS)


  • Cardio polmunary medical devices
  • Disposables and cannulae for circulatory support
  • Extracorporeal Perfusion systems for hemodialysis
  • Dental surgical equipment (piezoelectric devices, LED curing lamps, ultrasonic devices)
  • Absorbable and non-absorbable sutures for ophtalmic, dental, plastic surgery and cardiac applications
  • Thoracic catheters and wound drainage
  • Disposables for anesthesia and rianimation

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