IVDR Impact on Quality Management Systems

Why download?

IVDR’s impact on legal manufacturers’ quality systems means more documentation, more complexity, and increased interaction with stakeholders. 

We know this can be time-consuming and overwhelming. That’s why we’ve created this handbook to simplify the process, streamline compliance, and help you stay on track with minimal hassle.

 Inside, you'll find:

• The difference between IVDR vs. ISO 13485
• Quality Management System transition requirements 
• Lessons learned from gap assessments and changes you need to make in your QMS 

Plus, get answers to the industry's most frequently asked questions—IDU, labeling, PRRC qualifications, non-EU requirements, and more!