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.
Our experts work with your team to build a PMS system to match the class risk, and history of your products.
Our EDC is deployed to collect real world clinical data from sites and ePRO to meet PMS/PMCF requirements.
Our intelligence mines publicly available data sources to ensure breadth of the surveillance system.
Analytics trend and monitor risk and deliver insights to help drive quality improvement.
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.
To learn more about how Talosix can help you unlock the power of technology and artificial intelligence for your patients, please contact us.Contact Sales