A North American division of a global Japanese medical device manufacturer engaged RQMIS to address serious deficiencies cited in an FDA Warning Letter—specifically related to complaint handling, delayed investigations, and failure to close complaints in a timely manner.
At the time of engagement, the situation was critical:
The client needed more than temporary support—they needed a scalable solution to regain control quickly and sustainably.
Following a 45-day competitive evaluation against another consultancy, RQMIS was selected as the partner of choice based on our ability to deliver not just resources—but a repeatable, system-driven solution.
RQMIS assembled a cross-functional team including:
Each team member brought deep experience in complaint handling and post-market surveillance regulations, enabling immediate impact.
We developed advanced tools that analyze complaint data using keyword-driven logic to:
This transformed complaint handling from a manual bottleneck into a structured, repeatable workflow.
To eliminate inefficiencies and reduce investigation time, RQMIS developed:
These templates standardized:
Result: significantly faster, more consistent complaint resolution with reduced need for rework.
In just 7 months, RQMIS delivered measurable, high-impact results:
The value didn’t stop at backlog reduction.
The client adopted the tools and processes developed by RQMIS into their internal workflows, enabling:
RQMIS transitioned into a strategic support role, providing expertise as needed while the client maintains day-to-day control.
If you’re facing:
RQMIS delivers more than short-term relief—we build scalable systems that restore control and keep you compliant long-term.