Quality Management Support
Quality Management Support in Europe
Adapting your Quality Management System (QMS) to meet the requirements of the EU MDR 2017/745 can be a demanding task. Between internal audits, documentation updates, and regulatory interpretation, staying compliant—and efficient—takes time, expertise, and strategy.
That’s where Sobel comes in. Our tailored Quality Management Support services help you navigate EU regulations with clarity and confidence, optimizing your QMS to meet legal standards while improving overall performance.
How We Help Your QMS Meet EU Requirements
We offer hands-on support designed to meet your exact regulatory and operational needs.
We conduct detailed internal audits in line with EU MDR 2017/745 to assess the completeness and implementation of your procedures. This gives you a clear snapshot of where your QMS stands—and what you need to do next:
Audit Planning
Review of procedures for structure, scope, and compliance
Evaluation of how procedures are implemented within your company
Final Audit Report outlining findings, non-conformities, and actionable steps
Customized Compliance Strategy:
Our consultants help adapt your existing QMS, focusing only on what’s essential for MDR compliance. Whether you’re already ISO 13485-certified or working with an ISO 9001 quality management system, we align your system with MDR without adding unnecessary complexity.
Regulatory Communication Support:
We act as a bridge between your team and regulatory bodies—helping you interpret requirements, prepare for audits, and respond clearly and confidently to competent authorities.
Why do you need this service?
Through our internal audits, you’ll gain a detailed view of your current status, with a roadmap to bring your system into full alignment with EU MDR 2017/745.
Compliance doesn’t have to slow you down. Our team work to all regulatory adjustments are implemented with minimal disruption to your day-to-day operations.
Navigating quality management in Europe can be confusing. We simplify it—translating complex requirements into concrete actions.
Whether you’re scaling in Europe or preparing for your first CE mark, aligning your QMS with MDR is a strategic move. And you don’t have to do it alone! The highly qualified team at Sobel is here to be your strategic partner on this journey.
Need Quality Management Support?
At Sobel, we don’t just help you comply—we help you evolve. Our QMS support is practical, personalized, and designed to strengthen both your regulatory position and your internal processes.
Let us handle the complexities of compliance—so you can focus on delivering innovation, safety, and long-term growth.
Take the stress out of compliance with Sobel!
