Vigilance & Active Surveillance
Post-Market Surveillance (PMS) encompasses the systematic collection, analysis, and action on information about device performance after market release. Regulatory frameworks mandate PMS systems proportionate to device risk.
RegOps develops and supports PMS systems that meet regulatory expectations while generating actionable insights. We help you establish data collection processes, trend analysis methodologies, and escalation procedures that ensure safety signals are identified and addressed appropriately. Our PMS approach integrates vigilance reporting, complaint handling, clinical evidence collection, and quality system feedback into a coherent surveillance framework.
Our Capabilities
Robust surveillance systems for safety and compliance.
Development of post-market surveillance systems compliant with MDR, FDA, and international standards. We design processes, data sources, and analysis methods.
Alignment of complaint handling with PMS requirements, ensuring feedback is systematically captured, investigated, trended, and integrated into post-market assessment.
Implementation of trending methodologies to identify statistically significant increases in events. We establish analysis frequencies and escalation thresholds appropriate to risk.
Support for adverse event reporting including FDA MDRs and EU vigilance reports. We ensure reportable events are identified, assessed, and reported within required timeframes.
Authoring of Periodic Safety Update Reports (PSURs) and PMS Reports. We compile data, assess safety and performance, and document conclusions for regulatory review.
Support for Field Safety Corrective Actions (FSCA) planning and execution. We assist with health hazard evaluation, notification development, and authority communication.
The RegOps Advantage
We calibrate surveillance to detect meaningful signals while filtering noise, ensuring safety information receives appropriate attention.
Risk-Based Design
We design systems proportionate to device risk and volume, avoiding under-surveillance and over-engineering.
Operational Integration
Our designs integrate with existing quality systems and clinical data collection rather than creating parallel systems.
Regulatory Compliance
We ensure systems satisfy MDR/IVDR and FDA requirements with documentation that demonstrates compliance during audits.
Signal Sensitivity
We calibrate surveillance to detect meaningful signals without overwhelming your organization with noise.