Ms.Betty Lane

Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium-sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements while having a cost-effective Quality Management System.  Her background in digital systems engineering enables her to facilitate implementation of design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.
Betty’s training experience includes over 25 years of training on all aspects of FDA Quality System Regulation (cGMP) and ISO 13485, the ISO standard for Medical Device Quality Management Systems. She had done training in companies where she worked, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical device and biotechnology quality and regulatory affairs as at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.