Post-Market Clinical Follow-Up (PMCF) is an MDR-mandated process for medical device makers to assess a product’s real-world performance after release. Outlined in Annex XIV, PMCF collects clinical data to validate safety and effectiveness over time, adapting to diverse patient experiences.
Importance of PMCF: Like FDA surveillance, MDR demands up-to-date safety monitoring. PMCF delivers real-world data for design updates, label changes, or recalls, keeping manufacturers competitive. It pairs with literature reviews for a full performance picture, aiding regulatory decisions. It tracks safety and risks, like user errors, across a device’s lifecycle, ensures compliance to avoid fines, and speeds approvals with robust data.
PMCF activities vary by device risk—think user surveys, patient registries, adverse event tracking, and literature reviews. High-risk devices may need fresh clinical studies, while others lean on existing data. These tasks require meticulous documentation:
- Smarteeva turns complex PMCF processes into efficient workflows. Our AI-powered Salesforce solution automates the entire PMCF lifecycle.
- The platform simplifies PMCF setup by harnessing existing data as well as simplifying the integration of other data such as studies, literature and adverse events. It builds on technologies already employed for PSURs, MIRs, MDRs and risk management.
- Smarteeva consolidates all information and generates comprehensive reports with a single click.
- The Smarteeva AI Integration can analyze the numbers, write the report and make it ready for review by PMS staff. The system can even auto-email completed PMCF reports to regulators after review.
- With integrated data aggregation and advanced analytics, users can efficiently search, filter and analyze industry data, literature, complaints, adverse events and risk data.
These capacities allow for quick regulatory report generation while protecting time for value-added activities..
About Smarteeva
Headquartered in Dallas, Texas, Smarteeva Software pioneers Post Marke Surveillance for the medical device sector. We offer Complaint Handling, Adverse Event Reporting, Risk Management, and Recall Management solutions, designed for compliance and streamlined operations. Built on Salesforce.com with cutting-edge AI and Machine Learning, we are true partners to our users.
Reach us at: [email protected] | www.smarteeva.com
