EU MDR Compliance Solutions - Source Intelligence

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 manage your EU MDR compliance internally, utilize our expert-managed services to do the heavy lifting for you, or combine the two options, working with us will provide you with the peace of mind that your medical devices are EU MDR compliant.

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Key features of our EU MDR software:

Multi-tiered BOM management
Flexible modular platform
Integrations to all major PLM & ERP platforms

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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

Solutions to fit your needs

Product compliance

Identify risks to ensure every supplier, part, and product meets core compliance obligations.

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Responsible sourcing

Uncover exposure to suppliers engaged in conflict mineral sourcing, deforestation, human rights violations, and other areas of concern.

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Sustainability

Comply with the increasing number of sustainability policies and escalating consumer demands, including Extended Producer Responsibility (EPR) legislation.

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