Kyle is a certified quality auditor, and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. He helps medical device companies develop and maintain effective and efficient quality systems for all classes of medical devices including Software as a Medical Device (SaMD). His specialties include 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.