The RookQS team leverages its extensive experience and expertise in quality and regulatory strategies for emerging and established medical device companies to help our clients get their devices to market significantly faster than standard methods.
Our consultants provide clients with the necessary tools to comply with regulations in both domestic and international markets, with specialists in FDA regulations, MDSAP audits, ISO 13485:2016 compliance, and MDR conformity. Our diverse team works with a wide range of devices (including class I-III devices, SaMD, and IVDs).
RookQS’ team of experienced, certified Quality Engineers features 11 certified quality auditors (CQAs) for a variety of regulations, including FDA 21 CFR 820, ISO 13485:2016, MDSAP, and CE Mark under MDR.
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.
Andrew is a medical device innovation fellow who joined Rook Quality Systems in 2016 as a Software Quality Assurance Consultant, managing verification & validation testing and strategy on various medical device embedded software to ensure conformance to FDA software validation guidance and IEC 62304.
In 2020, Andrew was elevated to the position of General Manager of Rook’s Taiwan branch, where he led the launch of Rook’s first international branch office. Andrew oversees a team of five software quality engineers focused on helping clients in the Asia-Pacific region and around the globe with technical development, quality and regulatory strategy in the software as medical device space.