The FDA has recently posted new guidance regarding bench testing. FDA suggests including both test report summaries and complete test...
We are a consulting firm dedicated to helping medical device companies develop and maintain effective and efficient quality systems.
SERVICES
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.
EXPERIENCE
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.
RESOURCES
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.
OUR VISION
Our vision is to enable our clients to implement compliant Quality Management Systems (QMSs) so to ensure our clients can efficiently produce effective and reliable medical devices.
We help build the QMS so that our clients can get their devices to market faster than standard methods, and once on the market, use these systems to continue producing quality devices.
RECENT POSTS
The FDA recently released an Action Plan to address Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device...
