Unsure of how you’ll manage a QMS after its creation? Our expertise does not end at initial QMS creation and implementation. RookQS has a decade of experience managing the quality system for a wide range of medical device, SaMD, and IVD companies. Whether you have an existing QMS and no one to manage it, or you are considering a QMS from RookQS and are hesitant to commit resources to managing it, we have an expansive team of engineers to dedicate to your QMS Management.
Once paired with one of Rook’s experienced quality team, you will have quality personnel dedicated to your company. Early on, your dedicated quality manager and engineers are available to help with design and risk quality documentation, supplier qualification, QMS training management, and other pre-market QMS activities. When your company reaches the post-market phase, you can count on continued support from Rook’s engineers for activities including nonconformance management, CAPA management, customer feedback management, internal and supplier audits and more. Many companies struggle with the day-to-day questions and problems that pop up when managing a quality system; our team will assist with dedicated support and quick communication to ensure that you maintain complete confidence in your QMS.
Have a quality manager, but need quality support? At RookQS, we’ve seen first hand just how many resources it requires to get a med device company off the ground. We would be honored to share our experience and expertise and collaborate with you and your management team under your established procedures.
You will find this article helpful for understanding how Rook helps companies identify the critical steps needed to prepare your QMS for the upcoming EU Medical Device Regulations in 2020. Link to the Article: https://www.greenlight.guru/blog/qms-eu-mdr…