Rook Quality Systems

Rook Quality Systems is a consulting firm dedicated to helping early-stage medical device companies develop and maintain effective and efficient quality systems. For over a decade, Rook has specialized in Quality and Regulatory strategies for emerging medical device clientele. At Rook, our mission is to enable clients to implement compliant Quality Management Systems (QMSs) so 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 provides clients with...

Iso 13485,510(k) clearance,medical device quality systems,medical device software validation,quality assurance,post-market surveillance,internal audits,employee training,samd support,quality training,international regulatory affairs,dhf/tf creation,qms design,and qms management

Rook quality systems operates in the Medical equipment manufacturing industry.

Rook quality systems's revenue is 11m - 100m

Rook quality systems has 11 - 50 employees.