Since 2012, Rook has been dedicated to helping medical device companies develop and maintain effective and efficient quality systems, and to providing them with the right resources and expert insight. Our mission is to enable our clients to implement compliant Quality Management Systems (QMS) to ensure that they can efficiently produce effective and reliable medical devices. We build these QMSs so that our clients can get their devices to market faster than standard methods, and once on the market, manage these systems to continue producing quality devices.

Rook specializes in Quality and Regulatory strategies for early-stage medical device clientele, providing expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Rook works with a wide range of devices, including class I-III devices, SaMD, and IVD, collaborating with your team on a holistic approach to getting your device to market as efficiently as possible. Visit their website to learn more.