President
Rook Quality Systems
Session Tracks covered by Kyle
Talks covered by this speaker
4
How to get your COVID-19 Related Medical Device to Market Under FDA Emergency Use Authorization (EUA)
About this Speaker
Medical Device expert specializing in development of efficient Quality Systems for small and startup medical device companies. As President of Rook Quality Systems Mr. Rose works as a quality system advisor for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Mr. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QS design. Kyle is an expert in Quality System Development, ISO 13485:2016, 21 CFR 820, MDSAP ISO 14971, CE Mark Design Control, Risk Management, CAPA, Medical Device Software Validation, and Product Development.
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