Post-Market Surveillance
Post-Market Surveillance
From Complaints to Evidence
Manage complaints and review published literature in one system, with the information and reasoning your team needs to evaluate product performance.
Keep Post-Market Work Moving.
Complaint Management
Manage Complaints From
Intake Through Review.
Capture complaints from the sources your team already uses, organize the information into a controlled record, and keep follow-up, investigation, and review in one workflow.
Flexible intake
Capture complaints from email, transcripts, or direct entry.
Structured records
Organize complaint details, product information, dates, and codes.
Guided follow-up
Identify missing information and prepare follow-up for review.
Quality follow-up
Link complaints to related nonconformances and CAPAs when further action is required.
Literature Surveillance
Screen Published Evidence
Against Your Review Criteria.
Search published literature, evaluate results against your review protocol, and keep the reasoning behind each selection available for review.
Defined criteria
Set product information, selection instructions, and inclusion or exclusion criteria.
Literature search
Search connected literature sources across a defined coverage period.
Selection reasoning
See why each result was included or excluded.
Human review
Review and confirm selections before using the evidence downstream.
Post-Market Reporting
Prepare Regulatory Reports
From Traceable Source Data.
Bring post-market information into regulatory reports without manually compiling evidence across disconnected sources.
Post-market evidence
Use information captured through post-market activities in downstream reporting.
Source traceability
Keep report content connected to the information it came from.
Less manual compilation
Reduce the work of gathering and organizing information for each report.
Review before submission
Keep your team in control of report review and final decisions.
Explore Cytodyme
Post-Market Surveillance
Choose the solutions your team needs for complaint management and literature review.
Complaint Management
Capture, manage, and review complaints through a configurable post-market workflow.
Literature Surveillance
Search and screen published evidence against defined review criteria.
Still Have Questions?
Still have questions? We’ve got you covered.
If it’s not covered here, reach out or book a demo to see Cytodyme in action.
Can Cytodyme work with our existing complaint management process?
Yes. Complaint workflows can be configured around your existing process, including the information you collect, workflow sections, coding, and review steps. Cytodyme can also capture complaints from sources such as email and call center transcripts, so teams do not have to rebuild their process around a rigid system.
How does Cytodyme use AI in complaint management?
Cytodyme can help extract and structure complaint information, identify missing information, and evaluate complaint coding. Your team remains in control of review and regulatory decisions rather than having the system make those decisions automatically.
How does Cytodyme determine which literature is relevant?
Cytodyme evaluates search results against your defined literature review protocol, including selection instructions and inclusion and exclusion criteria. The system provides the reasoning behind each assessment, and your team can review and confirm selections before the evidence is used downstream.
Can complaints connect to our other quality processes?
Yes. Complaints can be linked to related quality records, including nonconformances and CAPAs, so the originating complaint and subsequent quality activity remain traceable within Cytodyme.
How does Cytodyme support post-market reporting?
Cytodyme can use information captured through post-market activities to support downstream regulatory reporting, reducing the work required to gather and organize source information. Report content can remain traceable to its underlying sources and available for human review.