Cytodyme

Cytodyme is an AI-enabled quality and regulatory workflow platform purpose-built for medical device and diagnostics companies. It automates post-market surveillance, complaint management, literature review, and regulatory reporting in a single connected system, replacing disconnected spreadsheets and manual documentation with structured, traceable, and audit-ready workflows. Cytodyme is designed for quality, regulatory, and post-market teams of all sizes — from early-stage MedTech companies to large enterprise device manufacturers.

Backed by Techstars, Cytodyme is built to reduce the documentation burden that consumes quality and regulatory professionals, enabling teams to focus on analysis and decision-making rather than assembling records. The platform is compliant with FDA 21 CFR Part 11, supports EU/UK MDR and IVDR workflows, and maintains end-to-end audit trails throughout every process.

Post-Market Surveillance and Complaint Management

• Manage complaints, investigations, and vigilance activities in one centralised place
• Apply consistent severity, risk, and reportability criteria across all product events
• Track trends across products, time periods, and regions to surface emerging safety signals
• Automatically group similar complaints together, even when described differently across intake channels
• Severity and patient impact assessments update dynamically as new facts emerge during investigations
• Track UDI, lot, serial number, and full product history together to surface siloed data
• Document clear, traceable rationale for why an event is reportable or not reportable
• Draft MDR, IVDR, and FDA regulatory reports directly from live, connected data

Post-Market Reporting and Documentation

• Automatically generate submission-ready post-market reports from connected, traceable source data
• Supports PSUR, PMPF, CER, MDR reports, and other required MDR/IVDR post-market reporting outputs
• Connect PMS data, supporting evidence, and decisions as they evolve over time
• Capture literature review and performance evidence with preserved citations and rationale
• Every change, decision, and approval is automatically recorded without additional manual effort

Literature Surveillance

• Run validated literature searches and screen evidence at the scale regulators expect
• Literature screening runs continuously in the background to keep post-market evidence current
• Produce audit-ready outputs for clinical evaluation and post-market surveillance obligations

Regulatory Change Monitoring

• 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

Lean Quality Management System

• A modern QMS designed to evolve alongside product changes, regulatory updates, and operational workflows
• Replaces repetitive reporting and disconnected files with AI-powered automation
• Designed to complement existing eQMS or document management tools rather than replace them
• Helps teams streamline post-market workflows, improve traceability, and reduce time spent assembling reports

Compliance Standards Supported

• FDA 21 CFR Part 11 and FDA 21 CFR Part 4
• EU/UK MDR and EU IVDR
• ISO 13485, ISO 14971, ISO 9001, ISO 17025, ISO 15189, and ISO 27001
• GDPR and CAP
• ICH Q10 and 21 CFR Part 820

Security and Validation Infrastructure

• Validation-ready infrastructure with system controls aligned to FDA 21 CFR Part 11, ISO 13485, MDR, and IVDR expectations
• Structured records, traceability, version control, and good documentation practices support inspections and audits
• Every action is logged, time-stamped, and attributable to a specific user
• Role-based access controls enforce least-privilege permissions across the platform
• Complete version history, approvals, and audit trails support inspection readiness and internal governance
• Encryption at rest and in transit, OAuth 2.0 authentication, and two-factor authentication
• Customer data is isolated and never used beyond its intended purpose; AI features do not train on customer content

Cytodyme integrates with existing quality, safety, and data sources to maintain continuity across workflows, making it straightforward to connect to an organisation's existing tool stack. The platform is designed to support regulated post-market workflows in medical devices and diagnostics, helping teams maintain compliance as requirements continue to evolve under MDR, IVDR, and FDA frameworks.