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Kyle Rose

Kyle Rose is a medical device expert, specializing in development of efficient quality systems for small and startup medical device companies. As President of Rook Quality Systems, Rose works as a the contract quality manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Rose 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. Mr. Rose encourages the simplification of quality systems to reduce the quality burden and improve compliance through training and efficient QMS design.

Mon, 04/02/2018 - 12:02
Understanding QMS Software Validation Requirements in ISO 13485:2016Quality system software validation is nonnegotiable
Mon, 04/02/2018 - 12:02
As I’m sure many of you know, the ISO 13485 standard for medical devices was updated in 2016, which means the time to transition your quality management system (QMS) is now. Most auditing organizations have either cut off ISO 13485:2003…
      

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