Prove Your Product Works—In the Real World
Getting approval is only the beginning.
Regulators now expect manufacturers to continuously monitor how their products perform in real-world use—not just in controlled clinical environments.
RQMIS helps you design and execute strategies to collect, analyze, and act on real-world data, so you can demonstrate ongoing safety, performance, and compliance.
Why This Matters
Clinical trials don’t tell the full story.
Once your product is on the market, it’s used:
- By broader patient populations
- In real-world conditions
- Over longer periods of time
That’s why post-market surveillance is required—it ensures your product continues to perform safely and effectively after launch.
The Challenge
Most companies struggle to turn real-world data into meaningful insight.
- Fragmented data sources (complaints, clinical data, user feedback)
- Limited visibility into product performance trends
- Reactive processes instead of proactive monitoring
- Difficulty linking data to regulatory requirements
The result? Missed signals, delayed responses, and increased regulatory risk.
The RQMIS Approach
Collect Real-World Data
We establish processes to gather data from multiple sources, including:
- Complaint handling systems
- Adverse event reporting
- Clinical follow-up studies (PMCF)
- Literature and registry data
This ensures you capture a complete picture of product performance.
Analyze & Identify Trends
Raw data isn’t enough—you need insight.
We help you:
- Detect emerging safety signals
- Identify recurring failure modes
- Monitor performance trends over time
- Evaluate benefit-risk profiles
Post-market surveillance requires systematic data analysis to identify risks and trigger corrective actions.
Feed Data Back Into Risk Management
Your product doesn’t stay static—and neither should your risk assessment.
We ensure real-world data is integrated into:
- Risk management files (ISO 14971)
- CAPA systems
- Design improvements and updates
Support Regulatory Compliance
We align your data and processes with global regulatory expectations:
- FDA Post-Market Surveillance (21 CFR Part 822)
- EU MDR PMS and PMCF requirements
- Global vigilance and reporting obligations
Because regulators expect continuous evidence—not one-time validation.
From Data to Decisions
Post-market surveillance isn’t just about collecting data—it’s about using it to make better decisions.
A strong system allows you to:
- Detect issues early
- Respond faster to risks
- Improve product performance
- Maintain continuous compliance
The Outcome
With RQMIS, you can:
- Demonstrate ongoing safety and effectiveness
- Strengthen regulatory compliance
- Reduce risk of recalls and adverse events
- Continuously improve your product
Don’t Stop at Approval
Your product’s real test begins after it reaches the market.
Let’s build a system that proves performance—and protects your business long-term.