Why is an MDR-compliant QMS essential in the EU?
Legal background
EU MDR compliant QMS is more than a regulatory requirement, it is the foundation of operational excellence, risk management, and product reliability. Without a compliant QMS, manufactuers risk delays in CE marking, regulatory penalties, or market exclusion.
Implementing a robust QMS allows manufacturers to:
- Ensure your medical devices meet EU regulatory requirements and perform as intended.
- Consistently deliver products that meet customer and statutory expectations.
- Identify risks and improvement opportunities across your operations.
- Strengthen customer confidence and regulatory credibility.
- Prepare your business for ISO 13485 certification and Notified Body audits.
Our services
QMS Solutions to Achieve MDR and IVDR Compliance
Obelis offers expert Quality Management System (QMS) support to help medical device and IVD manufacturers meet EU compliance requirements under MDR and IVDR. We guide you through gap analyses, provide QMS documentation templates, and offer training on ISO 13485 to prepare your team for implementation and certification. Our specialists also simulate audits to help you navigate the certification process with confidence. Whether you are building your QMS from the ground up or refining an existing one, Obelis ensures your system meets regulatory expectations and supports long-term performance and compliance.
We tailor our quality management system support to ensure your QMS is not only compliant, but also aligned with your operational needs and growth plans. Flexible consultation options are available as part of tailored service packages. Contact us to discuss your needs and receive expert QMS support for EU compliance.
FAQ
Frequently Asked Questions
A compliant QMS is not only a legal requirement under the EU Medical Device and In Vitro Diagnostic Regulations, but also a critical tool for minimizing risk, ensuring traceability, improving product quality, and securing CE certification. Without a QMS, market access is not possible for the majority of medical devices, and you risk enforcement actions, recalls, or rejection by Notified Bodies.
We ensure that your QMS meets both regulatory expectations and practical business needs. Obelis provides tailored QMS support for medical device and IVD manufacturers, including:
- QMS gap assessments and audits
- ISO 13485 compliance alignment
- Document drafting (SOPs, policies, technical files)
- Regulatory training and implementation guidance
- Readiness support for Notified Body audits
Obelis acts as your strategic compliance partner throughout the QMS implementation process. We provide hands-on support in building and documenting your QMS, aligning it with ISO 13485 and EU MDR/IVDR requirements. From creating compliant SOPs to preparing your team for audits, our experts streamline the path toward certification—ensuring your systems are not just compliant, but robust and scalable.
