Creating a Technical
File / Design Dossier

Course Outline When you place a medical device on the market in Europe, you must compile a technical file or design dossier as part of CE marking requirements. Other markets globally also require a similar set of technical documentation to support market clearance. This course guides you step-by-step through how to put together technical documentation with the focus on European requirements and incorporation of the enhanced requirements as a result of the adoption of the new Medical Device Regulation. The course includes what evidence and level of detail you need to supply in order to demonstrate your product conforms to relevant safety and performance principles.

We also show you how to use the STED (Summary Technical Documentation) format for technical files and design dossiers and how this can provide a baseline for global technical documentation convergence. By using this internationally recognised approach, you can ease the task of global regulators and thereby smooth the review process. Many companies find it reduces time to market and costs, so this course could be hugely valuable for your organisation – especially if you want a regulatory submission that is recognised across global key territories.

Topics covered

  • Introduction and definitions to technical files in global requirements
  • Brief Overview of the Global Harmonization Task Force (GHTF) and IMDRF
  • GHTF guidance including GHTF/SG1/N011:2008 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
  • Purpose and Use of the STED format
  • Technical File requirements for CE marking to the current Medical Device Directives and the key changes with the new MDR
  • EU conformity assessments
  • Changes affecting Technical files in the new Medical Device Regulation
  • How to incorporate the new EU requirements with existing STED format
  • Structure, layout and contents of Technical File including MDR requirements
  • Declaration of Conformity

Course outcomes
At the end of the seminar, delegates will gain an insight into:

  • A knowledge and understanding of the main requirements for Technical Documentation in the STED format
  • The ability to compile Technical Documentation in the STED format
  • The ability to upgrade existing Technical Documentation, Regulatory Submissions and compile new Regulatory Submission folders to the STED format
  • An awareness of those global markets that recognise the use of STED
  • An appreciation of the common pitfalls and mistakes within regulatory submissions
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