Postmarket Surveillance Service (PMSS)
Turn Postmarket Data Into a Competitive Advantage
Turn Postmarket Data Into a Competitive Advantage
Postmarket surveillance is no longer just about compliance—it’s about continuous product performance, risk visibility, and faster decision-making.
As global regulatory expectations increase, manufacturers must do more than collect complaints and submit reports. They must demonstrate a proactive, data-driven system that continuously monitors product performance, identifies emerging risks, and drives improvement.
RQMIS helps you build and operate a modern, scalable postmarket surveillance program that strengthens compliance, reduces risk, and improves product quality across the entire lifecycle.
Many organizations still rely on fragmented systems and manual processes—leading to:
Poor postmarket systems don’t just create compliance risk—they impact patient safety, brand reputation, and revenue.
RQMIS transforms postmarket surveillance from a reactive function into a proactive, integrated system.
We combine:
The result: a postmarket surveillance program that is audit-ready, efficient, and continuously improving.
We design and execute structured complaint handling processes that are compliant, consistent, and scalable.
Effective complaint handling is one of the most critical—and most frequently cited—areas in FDA inspections.
We ensure timely, accurate reporting to global regulatory authorities.
Our team helps you avoid underreporting, overreporting, and regulatory scrutiny.
We turn your postmarket data into actionable insights.
A well-structured PMS system enables early detection of quality issues and continuous product improvement.
When issues arise, response speed and documentation matter.
We help you respond decisively—while maintaining compliance and minimizing disruption.
Real-world data is critical to demonstrating long-term safety and performance.
Our PMSS programs are aligned with global regulatory requirements, including:
These frameworks require manufacturers to collect, analyze, and act on postmarket data continuously—not just react to issues.
Traditional postmarket surveillance focuses on reacting to complaints.
Modern systems go further:
This shift is now expected under evolving global regulations and quality system requirements.
With RQMIS, you gain:
Whether you need to build a program from scratch, fix compliance gaps, or scale operations globally, RQMIS provides the expertise and infrastructure to support you.
