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.
Quality is Everyone’s Job
Rose Medical has been certified to ISO 13485 since 2008. Our most recent ISO certificate:
As part of our ISO certification we have defined our Quality Policy in our Quality Policy Manual:
Rose Medical is a registered manufacturer with the United States Food and Drug Administration (FDA). FDA Registration Number: 1836324
