Kyle Rose Email & Phone Number

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 contract Quality Manager for multiple medical device companies, overseeing overall quality strategy, and ensuring compliance through documentation and auditing services. Mr. 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 QS design. Specialties: Quality System Development, ISO 13485, 21 CFR 820, ISO 14971, 510(k) submission, Design Control, Risk Management, CE Mark, Greenlight.Guru, Medical Device Software Validation, Product Development, Internal and Supplier Audits, CAPA, Complaint Handling, Supplier Approval, Verification and Validation.