Downloads - Guidance for your regulatory compliance

We are happy to share our knowledge with you when it comes to the regulatory compliance of medical devices and IVDs! Browse through our Whitepapers and if you are looking for something that you can't find here, feel free to contact us

(Available only in German Language)

We look forward to hearing from you!

"The Technical Documentation under the MDR"

4 Practical Guides for Adapting from MDD to MDR

Technical documentation under the MDR (1): Changeover of your existing products


A procedural model in 6 steps:
  • Organization of Your Products
  • Intended Purpose
  • Indication/Contraindication
  • Product Description
  • Classification
  • General Safety and Performance Requirements (GSPR)

Download part 1 (Completely free of charge)

"The Technical Documentation under the MDR (2): Successful GAP Analysis"


  • Analysis based on GSPR,
  • Detailed analysis of technical documentation, and
  • Post-market surveillance analysis

Download part 2 (Completely free of charge)

"The Technical Documentation under the MDR (3): Content Overview and Ideas for Structure"


  • Well-structured technical documentation in coordination with the Notified Body,
  • Relevant components of the technical documentation including examples

Download part 3 (completely free of charge)

"The Technical Documentation under the MDR (4): Closing Gaps and Post-Market Surveillance"


  • Closing Gaps,
  • Post-Market Surveillance, and
  • Detailed Update of the Technical Documentation

Download part 4 (Completely free of charge)

"The Technical Documentation under the IVDR"

Practical Guide for Adapting from IVDD to IVDR"

Cover zum Whitepaper Technische Dokumentation: So gelingt die Anpassung von IVDD auf IVDR


  • Transition of Existing Products to IVDR: Development of a Procedural Model
  • Successful GAP Analysis of Your Technical Documentation with Tips for Tables and Checklists
  • Closing the Gaps: The Gaps are Identified. What's the Systematic Next Step?
  • Content Overview and Expert Input on Specific Topics
  • Post-Market Surveillance

Download now (Completely free of charge)