How to establish a Quality Management System that produces
faster, cheaper, and efficient medtech development.

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Is your Quality Management System (QMS) a liability? Slowing progress through burdensome, overly complex procedures that leave your team vulnerable to audit findings?

A quality QMS is at the center of any medtech manufacturer’s success story!

Join Kyle Rose as he shares tips to building an effective Quality Management System that reduces costs, timelines, and most importantly, streamlines medical device development to accelerate growth.

Attendees will learn:

• The purpose of a QMS and compliance
• How to write lean SOP’s that demonstrate compliance and best practices
• How to document the process through clear and simple work instructions
• Which procedures to prioritize and where manufacturers go wrong
• Accessible training material published/produced by regulatory bodies

Learn from other’s mistakes – register now and create an effective QMS that works for you!

Meet our speaker:

Kyle Rose, President, Rook Quality Systems :

Rook Quality Systems' President Kyle Rose is a Medical Device expert specializing in the development of efficient Quality Systems for small and startup medical device companies. Kyle founded RookQS 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 audit experience for a variety of markets including FDA, CE Mark, Health Canada, MDSAP, and CFDA. Kyle encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design.