Our solutions
Are you preparing to launch your medical device in the European market? Sobel provides expert support to help your company navigate the EU MDR 2017/745 requirements and confidently achieve CE Marking certification. From regulatory strategy to technical documentation and conformity assessment procedures, we offer end-to-end support to ensure your device complies with European medical device regulations.
EU MDR Compliance and CE Marking Expertise
Regulatory Compliance Solutions for the European Medical Device Market
With deep knowledge of the EU medical device regulatory landscape, Sobel helps manufacturers align with the latest MDR requirements, working closely with Notified Bodies and guiding you through every step of the process.
Our team offers strategic planning for EU MDR compliance, development and review of technical documentation, support with clinical evaluation reports (CER), assistance in preparing for conformity assessments, guidance on post-market surveillance and vigilance reporting.
We also provide preparation for EUDAMED registration, alignment with ISO 13485 and risk management (ISO 14971), support in appointing an EU Authorized Representative if needed, and more!
Our Services in Regulatory Compliance Solutions
Our proactive approach simplifies the complex regulatory framework of the European Union. Whether you’re submitting for Class I, IIa, IIb, or Class III devices, we ensure full compliance with the latest MDR updates and help you engage effectively with your Notified Body.
Helping your medical device succeed in the European market. Explore the key steps of the EU MDR compliance process and how Sobel can support you.
Pre-Registration & Planning
Documentation & Risk Management
Clinical & Biological Evaluations
Quality Setup
Training
Regulatory Affairs Support
Navigate regulatory affairs with our service for MDR 2017/745 compliance and support.
Quality Management Support
Optimize your quality management system for EU MDR 2017/745 compliance with Sobel.
Risk Management
Risk management support, following ISO 14971, to help ensure compliance with MDR 2017/745.
Biological Evaluation
Experience in robust biological evaluation for medical devices, in line with the ISO 10993 series and MDR 2017/745.
Toxicological Risk Assessment
Let Sobel take care of your toxicological assessments in compliance with MDR 2017/745 and ISO 10993.
Clinical Evaluation
Clinical evaluation services, ensuring compliance with MDR 2017/745 in the preparation of the CER.
Person responsible (PRRC)
Achieve MDR 2017/745 compliance with our PRRC service, managing risk and safety.
Authorized Representative
Our team handles regulatory communication, technical documentation, and compliance.
Technical File Elaboration
Trust our dedicated problem-solving approach for your CE file needs.
Expanding into Europe’s medical device industry means navigating a highly regulated environment where EU MDR compliance and CE Marking are mandatory.
Sobel offers hands-on support to help ensure your product meets the required safety, performance, and quality standards.
From developing a robust regulatory strategy to preparing technical documentation and assisting with Notified Body assessments, we guide you through the process with clarity.
Manufacturers must also manage ongoing compliance, including post-market obligations and adapting to evolving regulations. Our team provides continuous support in quality management, risk assessment, and regulatory updates to keep your medical device compliant and competitive.
Partner with Sobel to make sure that your medical device has what it needs to enter and thrive in the European market. With our expertise, you can confidently navigate the complexities of the EU MDR.
Latest articles
Discover trends, tips, and expert insights to keep you ahead.
The Essential Role of PMS in Ensuring Compliance with MDR 2017/745: A Professional Guide
Understand the essential role of PMS in ensuring compliance with MDR 2017/745 and its impact on medical device safety and regulation.
MDR 2017/745 vs ISO 13485: Decoding Quality Management Requirements
Discover the key differences between MDR 2017/745 and ISO 13485 in quality management for medical devices.
Success in Product Design: The Importance of ISO 14971 in Medical Device Risk Management
Discover how ISO 14971 plays a crucial role in medical device risk management and ensures success in product design.
