Complaint Handling

Cytodyme's Complaint Handling is an AI-powered post-market surveillance (PMS) platform designed for medical device and in vitro diagnostic manufacturers that need to capture, classify, and review complaints within a single, auditable system. The platform is built to support regulatory accountability across global vigilance requirements — including FDA 21 CFR Part 803, 21 CFR Part 820, and EU MDR and IVDR frameworks — without requiring teams to overhaul their existing complaint intake workflows.

Rather than replacing the systems teams already rely on, Cytodyme sits on top of existing tools to surface trends, classifications, and reporting views in one structured workspace. Final regulatory determinations and submissions always remain with the user's team, ensuring human oversight is preserved throughout the process.

Centralized Complaint Intake

• Multi-source intake: Cytodyme pulls complaint data from tools teams already use today, including systems such as Salesforce and TrackWise, as well as other complaint and servicing platforms.
• Unified complaint view: All complaints are surfaced in a single structured, searchable workspace, eliminating siloed data across departments.
• Live filtering and search: Filter complaints by product, lot, status, source, or assigned owner to quickly locate relevant records.
• System of record preserved: Original complaint sources remain unchanged and fully auditable — existing intake workflows are not disrupted.

AI-Assisted Coding and Classification

• AI-assisted coding: The platform suggests complaint codes based on the content of complaint descriptions, reducing reliance on individual judgment and manual code list searches.
• Multiple code systems: Supports IMDRF and MedDRA classification schemes, with the ability to configure which dictionaries are used based on team preferences.
• Confidence-scored suggestions: Each coding suggestion is displayed with a confidence level to guide human review, and confidence thresholds can be configured so lower-confidence suggestions require manual intervention.
• Human approval required: All final coding decisions require explicit user confirmation, ensuring regulatory accountability is maintained.

Real-Time Risk Monitoring

• Live risk signals: Severity and frequency metrics update continuously as new complaints arrive, so teams are working with current information rather than waiting for periodic review cycles.
• Configurable risk matrix: Organizations can apply their own risk rules to align with internal quality standards and procedures.
• Pattern escalation: Rising complaint trends are flagged before they cross reportable thresholds, enabling earlier intervention.
• Historical context: Current risk posture can be compared against prior periods instantly to identify meaningful shifts over time.

Vigilance Review and Regulatory Reporting

• Reportability signals: Complaints that may require regulatory review are flagged early, helping teams act on time-sensitive global vigilance obligations sooner.
• Linked investigation context: Complaints can be connected to CAPAs, servicing records, and other related documentation for complete investigation traceability.
• Regulatory report generation: MDR and vigilance reports are generated in required formats, with full traceability from intake through to submission.
• Full audit history: Every review, update, and submission action is tracked by user, providing a complete and defensible audit trail.

Management-Ready Analytics and Reporting

• Live analytics: Always-current metrics are available without manual data assembly, enabling leadership-ready analysis at any time.
• Configurable dashboard: Key insights and trends can be customized to reflect the metrics most relevant to the organization.
• Audit-ready outputs: All reports are backed by traceable source data to support internal and external audits.
• On-demand export: Charts and tables can be downloaded for management reviews, audits, or regulatory submissions.

Cytodyme's Complaint Handling platform is designed to integrate with existing complaint management infrastructure — including Salesforce and TrackWise — without requiring changes to how complaints are captured today. It supports compliance with FDA and EU MDR/IVDR vigilance requirements by structuring data, surfacing reportability signals, and generating draft regulatory reports, while keeping final review and submission authority firmly with the user's team.