Betty Lane, Consultant – Medical Device/Regulatory Compliance

Betty Lane has over 30 years of experience in Medical Device quality assurance and regulatory affairs. She has established or updated quality systems for numerous small- and medium-sized medical device and diagnostic companies, enabling these companies to manage their business in compliance with FDA and ISO 13485 requirements and sell their products worldwide. Betty’s background in digital systems engineering has allowed her to facilitate design controls and software validation as part of FDA and industry requirements.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP. She has taught courses in medical quality and regulatory affairs as an Adjunct at Northeastern University, as well as AAMI Quality Systems Regulation and Design Control courses, which provide comprehensive training for both industry and FDA personnel.

Betty is a Member of the Advisory Board of DQS, Inc. and a worldwide RAB accredited ISO 9000/QS9000/AS9000 registrar for over 20 SIC categories. Betty is active in her local section of the American Society for Quality (ASQ) and is also a member of the RAPS, Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers, and the IEEE. Betty has been featured in the book, Journeys of Women in Science and Engineering: No Universal Constants, by Susan A. Ambrose, et. al., Temple University Press, 1997.

 

Betty has Degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an M.B.A. from Northeastern University.

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