The most helpful feature is the event capture option. Every time we get a data point, the app makes is easy to capture it and assign it to someone so it can be dealt with properly.

The app is specifically designed with MedTech in mind. There are built in workflows, document control and compliance tools that are aligned with ISO13485 and FDA. I dont have to spend half my day chasing some missed files or worry about the file not being up to date

We purchased a license in 2019, now is 2025 and still sticking with QMS Wrapper. It's been 6 years with this software, so this review will be long! The software continues to evolve with the changing regulatory environment, yearly introducing new features, yet the pricing for long-time customers has remained unchanged, since 2019! I really appreciate the priority support, the loyalty and respect we receive from the QMS Wrapper team. The onboarding was efficient, implementation and integration went smooth, but the continuous support is what we appreciate the most, our account representative, Timea answers on our questions within an hour. We had features requests- they were all implemented. In the beginning we only needed ISO13485 and 14971, but as our organization expanded, we needed to comply with additional standards: QMS Wrapper system proved to be flexible enough, we simply created our own workflows and forms, and the system was fully capable of supporting any new standard we added, easily added them into the CAPA module, Deviation, Training, or Risk Management. Through my 20+ years in the regulatory industry, I’ve worked with several QMS software solutions, enough to make meaningful comparisons. Small software often lacks the features needed, while large systems tend to be overly heavy, slow and complex; QMS Wrapper is comprehensive yet lightweight, easy to navigate with a modern interface. And I know that this review sounds like a paid post, but it is not, I never wrote a review for the past 6 years. I’m glad we found QMS Wrapper, and I’m more than happy to recommend it!