Sobel supports manufacturers with practical and targeted quality management for medical devices services, designed to strengthen existing systems, identify gaps, and support confident regulatory readiness in the European market.
Strong quality management for medical devices provides clarity, consistency, and control across regulatory activities.
Under the EU MDR, manufacturers must demonstrate that their quality management system is not only documented, but effectively implemented and maintained.
Targeted quality management services help identify gaps, clarify regulatory expectations, and support informed corrective actions without disrupting daily operations.
A structured approach to quality management for medical devices strengthens compliance, improves audit preparedness, and supports sustainable access to the European market.
Quality management for medical devices is a critical pillar for regulatory compliance under Regulation (EU) 2017/745. Sobel provides modular and flexible quality management for medical devices services, allowing manufacturers to address specific needs without engaging in full system redesigns.
The most appropriate service depends on your quality management priorities, regulatory stage, and the level of support your team requires.
Critical review of the existing risk management process, including the Risk Management Plan and Report, to identify gaps and propose improvement actions aligned with applicable standards.
Ongoing consultative support to address questions related to quality management topics. Requests are submitted through the project management platform and answered in writing by Sobel’s experts.
Assessment of existing quality management documentation against EU MDR requirements, assuming an ISO 13485 quality management system is already implemented.
If you’re unsure which service applies, Sobel provides initial guidance to map the right route and ensure full compliance.
A structured quality management for medical devices framework often connects with other regulatory and quality activities required under the European regulatory system. Sobel also supports manufacturers and importers through complementary services:
Internal audits supporting ISO 13485 compliance and notified body readiness in Europe.
EAR for medical devices, supporting regulatory oversight and access to the EU market.
Navigating quality management requirements in Europe requires more than documented procedures. Sobel provides targeted support to help manufacturers understand expectations, identify gaps, and maintain effective quality systems under EU MDR.
Get expert support and strengthen your quality management strategy in Europe.
1. What does quality management for medical devices involve under EU MDR?
Quality management for medical devices under the EU MDR involves establishing, maintaining, and continuously improving a Quality Management System (QMS aligned with ISO 13485) that supports regulatory compliance, risk control, documentation management, and post-market obligations throughout the product lifecycle.
2. Is ISO 13485 mandatory for medical devices in Europe?
While the EU MDR does not explicitly mandate ISO 13485 certification, it is the internationally recognized standard expected by Notified Bodies. In practice, an ISO 13485-aligned QMS is considered essential to demonstrate compliance with EU MDR requirements.
3. Can I request support for specific quality management topics only?
Yes. Sobel’s quality management services are modular. You can request targeted support such as gap analysis, critical process review, or monthly consultancy without engaging in full QMS implementation or redesign.
4. Does Sobel implement or update quality management system documents?
No. Sobel provides advisory and analytical support, including identification of gaps and structured recommendations. The development, update, and implementation of QMS documentation remain the responsibility of the manufacturer.
5. How does monthly quality management consultancy work?
Monthly consultancy allows manufacturers to submit quality management-related questions via a project management platform. Sobel’s experts provide written responses within the agreed scope. Requests requiring extensive analysis or formal reporting are handled through a separate proposal.
6. Is this service suitable for companies already certified to ISO 13485?
Yes. These services are particularly useful for organizations that already have an ISO 13485-certified QMS and need support aligning their system with EU MDR expectations, addressing specific gaps, or preparing for regulatory interactions.
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