ISO13485 Clarity is a small consulting firm led by Kevin A. McLellan. Mr. McLellan has provided regulatory and compliance services to many medical device entrepreneurs, developers, and manufacturers. This has included direct experience with all stages of the device life-cycle, including design, development, production, manufacturing, distribution, and post-market activities. See more at Services.
Mr. McLellan is a certified Lead Auditor for ISO 13485:2016 (thru BSI), and also has significant experience with ISO 14971 (Risk Mgmt), ISO 62304 (Medical Device Software), and ISO 27002 (IT Security).
Mr. McLellan’s career has also included wide experience in IT, including software development, security planning, risk management, and IT capital spending. He has held staff and management IT positions at Methodist Le Bonheur Healthcare, FedEx Corp., and Express Scripts. He has degrees from Rhodes College (BA) and the University of Memphis (MA).
Finally, Mr. McLellan also provides HIPAA compliance services to the healthcare industry, and has worked extensively with healthcare providers and Business Associates. See HIPAA Clarity