Technical documentation

We prepare the necessary technical documentation for the approval of your surgical instruments in the classes I (including Is, Im, and new for MDR class Ir), IIa, and IIb, according MDR 2017/745.

Technical Documentation
Technical Documentation

This includes:

  • Device description and specification
  • Information to be supplied by the manufacturer
  • Design and manufacturing information
  • Safety and performance requirements
  • Benefit-Risk Analysis and Risk Management
  • Product Verification and Validation
  • Clinical evaluation
  • Biological evaluation
  • Post market surveillance (PMS)