Technical File

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Technical File

Technical Files are a Key element in for the success of product approval. Merc will help you identify the most suitable file layout in order to fulfill all possible Regulatory Requirements (MDR 2017/745, US and STED model requirements).
Technical Files contain information about Essential Requirements, Design, Risk Management, Biocompatibility, Clinical Evaluation, Production, Labelling, Post-market surveillance.
We can review the existing data, arrange them in order to meet all requirements, and assist you in completing the most critical areas of your files, such as:

  • Review of the device classification according to the MDR Requirements
  • Gap analysis of your technical files according to the New Regulation 2017/745.
  • Identification of the Essential Requirements
  • Identification of the Harmonised Standard
  • Risk Management
  • Biocompatibility test Plan
  • Quality System Procedures
  • Post-market surveillance plan and report
  • Clinical Evaluation
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Technical File