About qmsWrapper
Built by MedTech teams who refused to accept chunky and rigid quality systems.
Our roots go back to 1998, building medical technology in heart health across teams in the USA, Canada, and Europe.
Why qmsWrapper Exists
Some teams worked on software, others on hardware, with several medical teams involved in research at various hospital centers. We needed to communicate, coordinate, and collaborate on the same tasks, events, and projects. Time zones were killers.
We were using disjointed, chunky, and very inefficient QMS software. Ping-pong is a fun game, but not when played with QMS. We could not deal with issues in an interactive way, and compliance became a nightmare, a paper layer added on top of our daily work.
We needed something that helped us work together, on the same files, on the same projects, live.
The Breaking Point
When we looked for QMS solutions on the market, things did not get better.
Most platforms were rigid, expensive, and built in a way that slowed teams down instead of enabling them. They forced companies to adapt to the software, killing flexibility, slowing innovation, and making compliance feel like a burden instead of a system.
That was not acceptable. So we made a decision: we would build the system we actually wanted to use.
What We Built Instead
We had to rethink our approach to quality and compliance, not as an afterthought, but as something built into the way teams already work.
We needed a QMS that was:
- Flexible enough to adapt to how teams actually work
- Structured enough to support any major regulatory standard
- Simple to implement
- Easy to maintain over time
Our eureka moment was when we realized compliance could be managed through quality itself. Instead of managing quality separately, it became integrated into projects, tasks, documents, and events, all working together in one connected system.
10 Years of Proven Real-World Use
qmsWrapper was first released to the public in 2016. What began in 1998 as a way to survive compliance has grown into something far more powerful.
Today, qmsWrapper is a comprehensive platform covering the full scope of quality management and compliance, with multiple layers of AI that help drive quality systems and support everyday tasks. The result: compliance becomes more natural, continuous, and scalable.
Over the past decade, more than 500 startups have used qmsWrapper to get audited and maintain FDA and CE compliance while continuing to grow and innovate. The mission has not changed: make quality and compliance work for teams, not against them.
Common Questions About qmsWrapper and Our Medical Device QMS
What is qmsWrapper?
qmsWrapper is a modern medical device quality management system designed to connect quality processes, design documentation, and regulatory compliance in a single platform. It helps MedTech teams manage product development and maintain traceability across their quality system.
Why was qmsWrapper created?
qmsWrapper was created by MedTech teams who, going back to 1998, were building medical technology across the USA, Canada, and Europe using disjointed, rigid QMS software. Existing platforms forced companies to adapt to the software, slowing innovation and making compliance feel like a burden. We built the system we actually wanted to use.
Who is qmsWrapper built for?
qmsWrapper is designed for medical device startups and growing MedTech teams that need to manage documentation, quality events, and regulatory compliance in one connected system.
How does qmsWrapper help medical device teams?
qmsWrapper makes compliance a natural part of everyday work. Teams manage projects, tasks, documents, and quality events in one connected system, with multiple layers of AI that reduce manual effort and keep documentation traceable across the product lifecycle.
Which regulations does qmsWrapper support?
qmsWrapper supports medical device companies working under major regulatory frameworks, including ISO 13485, FDA 21 CFR 820, and EU MDR. Over the past decade, more than 500 startups have used qmsWrapper to get audited and maintain FDA and CE compliance.
What is the vision behind qmsWrapper?
Our mission is simple: make quality and compliance work for teams, not against them. We believe compliance should be managed through quality itself, integrated into how teams already work, not bolted on as an afterthought.
