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 and until May 2021 also MDD 93/42/EEC.

Technical Documentation
Technical Documentation

This includes:

  • Device description and specification

  • Information to be supplied by the manufacturer

  • Design and manufacturing information

  • General safety and performance requirements

  • Benefit-Risk Analysis and Risk Management

  • Product Verification and Validation