MedTech Results is a specialized consulting firm led by Kevin A. McLellan. MTR has provided FDA regulatory and Quality services to many medical device entrepreneurs, developers, and manufacturers. This has included direct experience with all stages of the medical device life-cycle, including design, development, production, distribution, and post-market activities.

Kevin 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). Kevin is a Member of the Regulatory Affairs Professional Society (RAPS), and has written for national healthcare technology publications. More at LinkedIn.

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 mgmt 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.