WHAT IS IMPORTANT TO ROOK
Our company specializes in quality and regulatory strategy for emerging and established medical device companies.
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 want to build these QMSs 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.
Our consultants provide our clients with the necessary tools to comply with regulations in domestic and international markets. Rook QS provides expertise in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. We work with a wide range of devices (including class I-III devices, SaMD, and IVDs).
WHAT'S IMPORTANT TO ROOK QUALITY SYSTEMS