Rose Medical has been certified to ISO 13485 since 2008 and is a registered medical equipment and device manufacturer with the FDA. For additional documents and information please visit our medical equipment engineering company’s resources page.
At Rose we have made an intentional decision to define our quality department differently than most medical engineering companies. We feel that making product quality the job of one group of people allows others to feel they are not responsible for it. Instead, our medical equipment and device manufacturers have decided to make quality critical to everyone’s job by cross-training employees at all levels about the importance of quality and the best way to implement it into projects from the earliest phases.
When we decided to obtain our ISO 13485 certification in 2008 we decided that the quality system needed to be highly automated to be efficient. As a result, we have designed and built our own quality system software that we call the ‘Quality Systems Database’ or ‘QSD’. This software is tailored to how the medical equipment and device manufacturers at Rose build our calibration, document control, training, and other systems right into our production in real time. The software is validated and CFR 21 compliant and we are constantly adding to it and improving it for better control and functionality. When you come visit our medical equipment engineering company we’d be happy to show you how our QSD makes quality control in manufacturing a snap.