Master PMCF Compliance with Intellicure Analytics
Ensure your wound care devices meet Europe’s Post-Market Clinical Follow-up (PMCF) regulations with ease. Leverage Intellicure Analytics’ robust, real-world data solutions to monitor safety, quality, and performance throughout your device’s lifecycle. Discover how our advanced analytics empower manufacturers to meet PMCF requirements efficiently and confidently.
Understanding PMCF Regulations
The European Union’s Post-Market Clinical Follow-up (PMCF) regulation, effective since 2020, mandates that medical device manufacturers actively collect and analyze data on their devices’ safety, quality, and performance throughout their lifecycle. This includes substantiating clinical claims, identifying side effects, emergent risks, interactions with other products, and off-label use, especially in high-risk populations like the elderly. Meeting these requirements in real-world settings can be complex—but Intellicure Analytics makes it seamless.
Actionable PMCF Outcomes for Wound Care
Intellicure Analytics empowers manufacturers to derive clinically relevant outcomes to meet PMCF requirements. Our platform supports:
- Objective Outcome Tracking: Beyond wound closure and surface area reduction, we measure critical indicators like bioburden, infection, peri-wound characteristics, exudate type, and volume.
- Custom Comparator Arms: Compare your device to the standard of care (SOC), similar product categories, or your existing portfolio using data on hundreds of dressings, CAMPs, NPWT products, and more.
- Risk Assessment with WHI: Utilize the validated Wound Healing Index (WHI) to create matched cohorts for precise risk-benefit analysis.
- Adverse Event Monitoring: Identify potential issues like product allergies, worsening wounds, hospitalizations, or amputations through clinical feedback.
Our methodology is backed by multiple peer-reviewed studies, and our independent Investigational Review Board (IRB) ensures ethical compliance for all data analyses. Click here to request a demonstration of our PMCF programs.
The Intellicure Analytics Advantage for PMCF
Intellicure Analytics transforms PMCF compliance with a cutting-edge, wound-care-specific electronic health record (EHR) system and a powerful analytics platform, eliminating the inefficiencies and biases of traditional registries.
How we empower manufacturers to meet PMCF demands:
Comprehensive, Bias-Free Data
Our EHR captures brand-specific data on all wound treatments across over 140 clinics in 32 U.S. states and Puerto Rico, ensuring a diverse, representative patient population without selection bias. Data from over one million patient visits provides a robust, real-world dataset.
Wound-Specific EHR Design
Optimized for point-of-care data collection, our system enables accurate diagnosis and tracking of complex cases, including arterial ulcers and patients with multiple wounds of different etiologies, while supporting compliant billing and home health orders.
Streamlined Data Delivery
Research-ready, deidentified data is transmitted nightly to our platform, eliminating manual secondary data entry and ensuring efficiency.
Tailored Clinical Insights
We create detailed clinical concepts to capture all relevant wound types, from acute wounds to chronic ulcers, ensuring comprehensive data for PMCF requirements.
Advanced Outcome Tracking
Measure critical indicators like bioburden, infection, peri-wound characteristics, and exudate type, beyond just wound closure or surface area reduction.
Custom Comparator Arms
Compare your device to the standard of care (SOC), similar product categories, or your existing portfolio using data on hundreds of dressings, CAMPs, and NPWT products.
Risk Assessment with WHI
Utilize the validated Wound Healing Index (WHI) to create matched cohorts for precise risk-benefit analysis.
Adverse Event Monitoring
Identify potential issues like product allergies, worsening wounds, hospitalizations, or amputations through clinical feedback.
Take Control of PMCF
Let Intellicure Analytics help you navigate the complexities of post-market surveillance with our innovative data solutions. Fill out the form below to speak with our team and discover how we can support your PMCF needs.
The Intellicure Analytics Data Platform
From Data to
Day-to-Day Decisions,
All in One Platform.
Your customized wound care data dashboard.
- Build actively-updated visuals structured on data that strictly pertains to your business interests
- Access your previously published Comparative Effectiveness Studies.
- Enter the Data Lab to conduct your own analytics using whatever toolsets you typically work with.
- Track real world data use and safety surveillance for your PMCF objectives.
- View the progress of your own custom wound care registry.
- Monitor your wound care device clinical trials.
- View any of your Intellicure data projects in one location!
