The global medical device market, valued at approximately $485 billion in 2022, is projected to nearly double to $965 billion by 2030. As competition intensifies, MedTech companies face increasing pressure to not only innovate—but to prove ongoing safety, performance, and compliance in the real world.
At the same time, the cost of quality is rising fast.
According to McKinsey, the medical device industry spends $26–$36 billion annually on quality assurance. In the U.S. alone, companies spend an additional $2.5–$5 billion each year addressing non-routine quality events—such as FDA observations, recalls, warning letters, consent decrees, warranties, and litigation. A single major event can cost up to $600 million.
That’s not just a compliance issue—it’s a direct hit to revenue, reputation, and market position.
The Opportunity: Get Ahead of Quality—Don’t React to It
Companies that treat post-market surveillance as a reactive function will always be playing catch-up.
The ones that win build systems that:
- Detect issues early
- Resolve complaints efficiently
- Identify trends before they escalate
- Feed real-world data back into product improvement
This is where RQMIS comes in.
A More Effective Approach to Complaint Handling & Adverse Event Reporting
Building on proven success supporting global MedTech clients, RQMIS has developed a structured, scalable Complaint Handling and Adverse Event Reporting service designed to help companies regain control of their post-market surveillance operations.
We don’t just process complaints—we help you build a system that works.
What We Deliver
Complaint Handling That Scales
We help design and support complaint handling processes that are consistent, efficient, and audit-ready.
- Structured intake, triage, and investigation workflows
- Standardized approaches to root cause analysis
- Improved cycle times for complaint closure
- Scalable support to reduce or eliminate backlog
Data-Driven Trending & Insights
Complaints are more than records—they’re signals.
We help you:
- Identify recurring failure modes
- Detect trends across products and geographies
- Feed insights into risk management and design improvements
- Strengthen overall product performance
Adverse Event Reporting You Can Trust
Regulatory reporting must be accurate, complete, and on time—every time.
RQMIS supports:
- Identification of reportable events
- Preparation and submission of adverse event reports
- Compliance with FDA and global regulatory requirements
- Documentation that stands up to inspection
Adverse Event Reporting You Can Trust
Regulatory reporting must be accurate, complete, and on time—every time.
RQMIS supports:
- Identification of reportable events
- Preparation and submission of adverse event reports
- Compliance with FDA and global regulatory requirements
- Documentation that stands up to inspection
Built for a Growing, High-Stakes Market
As the medical device market continues to expand, the companies that succeed will be those that can scale quality and compliance without scaling cost and complexity.
RQMIS gives you the structure, expertise, and execution to do exactly that.