Chris Harmston Email & Phone Number

A scientific professional specializing in quality, regulatory, and information systems with over 20 years experience working for start-up and established companies in a wide range of industries including clinical laboratory diagnostics, forensic biology, medical device design and manufacturing, and fall arrest safety equipment. Direct experience leading and creating regulatory submissions (FDA and CE) for implantable medical devices (PMA, 510k, CE Marking, 522 Order, etc.) and fall arrest equipment (CE). Excellent working relationships with regulators and scientific professionals. Successful PMA Supplements include site changes, design changes, manufacturing changes, labeling changes, annual reporting, and post market surveillance (180-Day, 30-Day, and Real-Time supplements). Developed, implemented, and maintained accredited quality management systems under 21 CFR 820, ISO 13485, ISO 17025, ISO 9001, CLIA, ASCLD-LAB, NYSDOH, and AABB regulatory requirements. Directed laboratory information management system software development and application administration.Expert in Document Control, Design Control, Supplier Control, Process Control, Process Optimization, CAPA, Validation, Cost Control, etc.Professional consultant in quality systems development, regulatory guidance, information systems and expert witness for the design, labeling, manufacturing, and use of rock climbing, ice climbing, mountaineering and rappelling equipment.LEAN\​6-Sigma Certified.Software: Microsoft Office, Microsoft SQL-Server, UNIFlow, PaperFlow, PaperVision, MRP systems.

Listed skills include Quality Management, Quality Assurance, Regulatory Affairs, Ce Marking, and 46 others.