EU Technical Documentation Review & Compilation

Technical documentation can be referred to by any number of names—technical file, EU documentation, Product Information File, Product Information Packet and more.

The bottom line is that for your products to legally enter the EU Market and continue to circulate, you must have valid documentation which demonstrates that they are safe for the end-user and are reflective of the essential safety and health requirements as laid out in the relevant legislation.

Each manufacturer is responsible for creating their own technical documentation and in most—if not all cases—must provide a declaration of conformity thereby declaring compliance with the law.

Finding the time or expertise to create a fully compliant EU technical file among other competing projects and priorities can be a challenge for many small to medium-sized manufacturers.

Obelis can support you in creating such technical files from scratch.

Our technical file related services include:

  • EU Technical File Compilation
  • Technical File Review  & Gap Analysis
  • MDR/IVDR Technical File Gap Analysis
  • Clinical Evaluation Report
  • Product Information File
  • Notified Body Selection
  • Notified Body Negotiation

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