PMS

Cytodyme's Post-Market Surveillance (PMS) platform is an AI-enabled, connected system designed for regulatory and quality teams responsible for monitoring real-world device performance after market release. It brings together complaint management, literature surveillance, and regulatory report generation into a single environment, replacing fragmented manual processes with continuous, automated oversight.

The platform is built for medical device organisations that need always-on visibility into post-market risk — enabling teams to detect safety signals as they develop, maintain audit-ready evidence, and produce the structured reports required by regulators, all from one connected system.

Complaint Management and Safety Signal Detection

• Multi-source intake: Complaints are pulled automatically from tools and systems teams already use, consolidating data without requiring manual re-entry.
• Vigilance workflows: Investigation status, related records, and reportability assessments are tracked in a single unified view, supporting end-to-end complaint handling.
• AI-assisted coding: Artificial intelligence helps code and categorise complaints, enabling teams to isolate trends by device, SKU, or specific configuration.
• Live risk signals: Severity and frequency metrics update dynamically as new complaints arrive, giving teams a continuously current picture of emerging risk.

Automated Literature Surveillance

• Unified search: The platform queries multiple sources — including PubMed and Google Scholar — simultaneously, eliminating the need to run separate searches across databases.
• Protocol-based screening: Abstracts are automatically screened against user-defined inclusion criteria, removing the burden of manual abstract review and reducing screening time.
• Audit-ready outputs: All surveillance results are backed by traceable source data, ensuring that evidence used in reports can be verified and defended during audits.
• On-demand export: Charts and tables can be downloaded at any time for use in regulatory reviews or audit submissions.

Regulatory Report Generation

• Automated PMS reports: The platform generates structured drafts for core post-market reports including the Post-Market Surveillance Evaluation Report (PSER), Post-Market Performance Follow-Up (PMPF), and Clinical Evaluation Report (CER).
• Traceable inputs: Every section of a generated report links directly back to its underlying source data — complaints, literature, or other connected records.
• Linked changes: When source data is updated, the platform automatically surfaces which report sections are affected, keeping drafts aligned with the latest evidence.
• Review before submission: Teams retain full control over final report content and the approval process before any submission is made.

Cytodyme's PMS solution is aligned to current regulatory standards and is designed to support both ongoing compliance and periodic reporting obligations. By connecting complaint data, published evidence, and report generation in one traceable system, it reduces the manual effort associated with post-market activities while strengthening the auditability of every output.