Device Makers

The Need for Proactive Surveillance (PMS)

Medical Device Companies are being required by EU MDR to move from reactive processing of complaints and reports of adverse events to proactive surveillance of product use in real world settings to keep their products in the EU market.

SOLUTION BENEFITS

PMS/PMCF for EU MDR Compliance Solution by Talosix

Collects data proactively and systematically.

Structures data for comparison across similar devices on the market.

Trends and monitors data to identify risks and potential issues.

Delivers insights to inform corrective and preventive actions and improvements in the quality of the device.

How It Works

Solution Design & Implementation

Our experts work with your team to build a PMS system to match the class risk, and history of your products.

Electronic Data Collection

Our EDC is deployed to collect real world clinical data from sites and ePRO to meet PMS/PMCF requirements.

Integrate Other Data sources

Our intelligence mines publicly available data sources to ensure breadth of the surveillance system.

Reporting & Analytics

Analytics trend and monitor risk and deliver insights to help drive quality improvement.

We work with top global device makers

Talosix works with the largest medical device manufacturers in the world to help meet their EU MDR PMS requirements and has successfully delivered Real World Evidence to CMS to drive reimbursement coverage decisions.

Do You Have the Data You Need?

To learn more about how Talosix can help you unlock the power of technology and artificial intelligence for your patients, please contact us.

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