Downloads - Guidance for your regulatory compliance

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

(Please note: The guide is only available in German. However, you can easily translate the PDF using standard online translation tools for better accessibility.)

We look forward to hearing from you!

"The Technical Documentation under the IVDR"

Practical Guide for Adapting from IVDD to IVDR"

Cover of the white paper Technical documentation: How to successfully adapt from IVDD to IVDR

Content

  • 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)

Whitepaper on Digitized Processes in Regulatory Affairs: How to Successfully Achieve Digital Transformation

Efficiently Master Regulatory Affairs Processes

Contents

Regulatory requirements for medical device manufacturers have been continuously increasing for years. The Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) have added complexity to approval and quality management processes. At the same time, companies need efficient processes to remain competitive in global markets.

This white paper examines how digitalized processes for regulatory affairs (RA) can be implemented in practice. The focus is on a return on investment (ROI) that is financially viable for medical device manufacturers.

Download now to transform your processes effectively.

Medical Device Regulation (MDR): Guide and introductory aid for manufacturers and suppliers

developed by VDMA HealthTech and Metecon

Contents

The MDR presents significant challenges for both medical device manufacturers and suppliers: increased transparency, new responsibilities, and stringent regulatory requirements demand a shift in thinking and closer collaboration.

This guide, developed in cooperation with VDMA HealthTech, provides practical insights to help you better understand MDR requirements and foster successful cooperation between manufacturers and suppliers.

Please note: The guide is only available in German. However, you can easily translate the PDF using standard online translation tools for better accessibility.

Download now and gain valuable insights!