Cytodyme

Cytodyme is an AI-enabled quality and regulatory workflow platform purpose-built for medical technology companies. Backed by Techstars, Cytodyme automates post-market surveillance, complaint management, literature review, and regulatory reporting, replacing disconnected files and repetitive manual processes with a single, connected system designed for quality, regulatory, and post-market teams.

The platform is FDA 21 CFR Part 11 compliant, supports EU MDR and IVDR workflows, and maintains end-to-end audit trails throughout every process. Cytodyme connects post-market data, supporting evidence, and decisions as they evolve, enabling teams to stay audit-ready at all times without additional administrative burden.

Core Platform Modules

• Post-Market Reporting: Automatically generate post-market and submission-ready reports from connected, traceable source data, including PSUR, PMPF, CER, MDR reports, and other required post-market outputs.
• Complaint Management: Capture, assess, and act on product issues before they escalate. Centralize complaints from every intake channel, assess patient risk and reportability, and manage investigations in a single system.
• Literature Surveillance (PMS): Run validated literature searches, screen evidence at scale, and produce audit-ready outputs for clinical evaluation and post-market obligations. Literature screening runs continuously in the background to meet the scale regulators expect.
• Lean Quality Management System (QMS): A modern approach to quality management, designed to evolve alongside product changes, regulatory updates, and operational workflows.

Post-Market Surveillance Capabilities

• Manage complaints, investigations, and vigilance activities in one centralized place.
• Apply consistent severity, risk, and reportability criteria across all events.
• Track trends across products, time periods, and regions to surface emerging safety signals.
• Connect PMS data, supporting evidence, and decisions as they evolve into audit-ready reports.
• Capture literature review and performance evidence with preserved citations and rationale.
• Support PSUR, PMPF, CER, and other MDR/IVDR post-market reporting workflows.

Complaint Management Features

• Pain-free complaint intake: Automatically group similar issues, even when written differently, reducing manual triage effort.
• Dynamic risk assessment: Severity and patient impact scores adjust automatically as new facts emerge during an investigation.
• Siloed data surfacing: Track UDI, lot, serial number, and full product history together in one view.
• Clear reportability decisions: Document and justify why an event is reportable or not, creating a defensible record.
• Faster regulatory reporting: Draft MDR, IVDR, and FDA reports directly from live, connected data.

Regulatory Intelligence and Compliance

• Monitor updates to regulations, guidance documents, and standards across multiple regions.
• Identify which products, documents, and reports are impacted by regulatory changes.
• Maintain a traceable record of what changed, what was reviewed, and what was updated in response.
• Stay current as MDR/IVDR and other regulatory requirements continue to evolve.

Compliance and Audit Readiness

• Every change, decision, and approval is automatically recorded without requiring extra manual steps.
• Designed to support EMA and FDA 21 CFR Part 11 electronic records and signature requirements.
• End-to-end audit trails are maintained across all modules and workflows.
• All regulatory workflows are connected in one system, eliminating fragmented documentation and disconnected files.

Cytodyme is built specifically for the way regulatory and quality teams work in the medical device industry, offering a unified platform that keeps post-market obligations under control while reducing the time and effort required to meet increasingly complex global compliance requirements.