Virtual Happy Hour: Right Sizing Your Medtech Company's Quality System

Right Sizing Your Medtech Company's Quality System

Speakers Bio:   

Kyle Rose: Kyle is a Medical Device expert specializing in the development of efficient Quality Systems for small and startup medical device companies. Kyle founded Rook Quality Systems in 2012 to enable clients to implement compliant Quality Management Systems (QMSs), and to ensure that clients can efficiently produce effective and reliable medical devices, Rook has been overseeing overall quality strategy and ensuring compliance through documentation and auditing services for nearly a decade.  

Kyle is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Kyle encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design.