We are a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems.
We provide specialized and custom consulting services for all classes of medical devices including Software as a Medical Device (SaMD). Let Rook QS help provide your company with the right resources and expert insight.
We complete over 20 notified body and regulatory audit days per year and support multiple submissions, full design verification projects, usability tests, clinical evaluations, and more.
With so many standards and updated regulations, it can be challenging. We provide your company with the right resources to help from design through to commercialization and post-market monitoring.