EU MDR
Our EU MDR technology
The European Union Medical Device Regulation (EU MDR) restricts the use of hazardous substances in medical devices placed on the EU market and establishes reporting requirements for devices containing any restricted substances over a certain threshold. The regulation’s complex classification system determines how compliance is achieved, which requires companies to have a thorough understanding of the regulation and how their devices are classified. This quickly becomes overwhelming for many companies and exposes them to uncertainty and risk, which can lead to fines, litigation, and product recalls.
Source Intelligence’s EU MDR platform helps reduce the uncertainty around EU MDR compliance and streamline the compliance process, including understanding how to classify your medical device(s), gathering clinical evidence, and collecting data. We help facilitate supplier engagement, data analysis, and documentation generation based on the level of support your business requires. Whether you want to leverage our software to self-manage your EU MDR compliance efforts or utilize our expert-managed services to do the heavy lifting, we’ll provide you with the peace of mind that your medical devices are EU MDR compliant.
Key features of our EU MDR software:
- Multi-tiered BOM management
- Flexible modular platform
- Integrations to all major PLM & ERP platforms
Our EU MDR program empowers you to:
Reduce internal resource burdens
Streamline due diligence efforts, such as supplier engagement, data collection, and report generation, and refocus internal resources on managing other parts of your business.
Minimize business risk
Easily provide documentation on demand. Your compliance data is housed in a centralized location, so you can efficiently generate reports and declarations to fulfill customer requests.
Gain supply chain visibility
Quickly identify issues with a complete view of your compliance and product data. Our configurable dashboards and BOM rollups display compliance verdicts for every part and component.
Increase risk foresight
Our regulatory experts guide our solution development, ensuring you have the right tools to anticipate changes to your compliance obligations and setting you up for compliance success.
Common questions about our EU MDR program
Topics to explore further
EU MDR Compliance: A Complete Guide
Product Compliance for Medical Device Manufacturing
6 Best Practices for Product Compliance Management
Solutions to fit your needs
Streamline compliance with our EU MDR solution
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