Qualio has been super helpful to us feeling like we have all the pieces in place for quality management system...to an FDA standard.
I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail.
We evaluated all players on the market ... and came up with Qualio as the best balance of price, capability, and quality of support. Really like the change event management, API flexibility, training tracking, and customer success support.
Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally.
For those just starting out, the Qualio Plus service fits right in to ensure a smooth transition to a new eQMS. Their diligent team has helped ensure our QMS implementation was smooth and effective, offering excellent advice every step of the way.
“A digital trail is so important in medical devices, particularly around field servicing and updating. It is just lovely to know that you have these automatic links and alerts, so you know that two years from now and you are looking back, you will find it.