Transforming Medical Device Complaint Coding with Speed and Precision.
Automates complaint coding instantly with AI-driven precision.
Captures and codes all issues within a single complaint.
Achieve seamless adherence to EU MDR and FDA guidelines effortlessly.
3Analytics’ IMDRF Coding Solution simplifies medical device complaint management with AI-driven automation. By assigning accurate IMDRF codes in real-time, it minimizes human errors, handles multiple allegations effortlessly, and ensures compliance with evolving regulations.
Adaptable to EU MDR and FDA guidelines, this solution integrates seamlessly into existing workflows, enhancing safety signal detection, efficiency, and regulatory accuracy while cutting costs by up to 72%.
IMDRF ensures accurate coding, reduces costs, and boosts efficiency. It’s a comprehensive AI-driven solution for handling medical device complaints with precision and compliance.
1. Enhanced Accuracy
AI-driven coding minimizes errors, ensuring compliance with EU MDR and FDA standards.
2. Cost Reduction
Automates complaint handling, cutting processing costs by up to 72%. *
3. Improved Efficiency:
Handles multiple allegations in a single complaint, speeding up workflows and reducing manual effort.
4. Regulatory Adaptability:
Real-time updates align with evolving global compliance requirements effortlessly.
Transforming Medical Device Complaint Coding with Speed and Precision.
Unleash unparalleled features to revolutionize your coding accuracy and compliance efficiency.
The solution seamlessly connects with your existing System including Quality Management System (QMS) to centralize complaint data for streamlined access and processing.
Accurate coding outputs are generated in real time, ready for regulatory reporting and submissions.
Aligns with global regulatory frameworks, such as EU MDR and FDA guidelines, for consistent adherence to compliance requirements.
By automating complaint handling, the solution reduces manual coding efforts, minimizes errors, and improves operational efficiency
The AI-driven platform identifies patterns in data, enabling earlier detection of potential safety signals and proactive risk management.
Eliminates manual coding efforts, minimizing errors and enhancing reporting accuracy.
Simplify complaint coding with our AI-driven IMDRF solution. Enhance accuracy, reduce costs, and ensure compliance.
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