|Leonard (Leo) Eisner|
Leo Eisner is the head of Eisner Safety Consultants, a firm that specializes in helping clients through the product safety and international regulatory processes (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.). The firm specializes in Medical, In Vitro Diagnostic, and high tech devices. Assistance to clients is provided with a team of experts that interface with the Safety Agencies and Regulatory Bodies, preparing the product for testing, regulatory submittals, and quality system certification. The firm also provides training for all these areas, along with assisting clients with risk management, in the development of international standards, and creation and implementation of quality systems.
Leo is a registered Professional Engineer in the Safety Engineering discipline. He has worked at some of the Leading Safety Agencies in the world and has over 25 years experience in the Product Safety arena. He worked at UL for 9 years in a wide variety of product categories, and then joined TÜV Product Service for several years specializing in electrical medical products. He later joined Karl Storz Imaging and worked for them for 2-1/4 years as a Compliance Engineer and has been consulting for over 10 years in product safety, quality systems, standards development, CMDR and CE Marking. Leo is a member of the US TAG for TC 62 (Electrical Equipment in Medical Practice), SC 62A (Common Aspects of Electrical Equipment Used in Medical Practice) and SC 62D (Electromedical equipment). Mr. Eisner is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery”. Leo is a member of RAPS, AAMI, ASQ & IEEE.
He is a coauthor of the MD&DI articles “A Primer on IEC 60601-1,” published September 2003, “National Deviations to IEC 60601-1,” published February 2004, “IEC 60601-1: Medical Device Marking and Labeling,” published in May 2004, “Leakage Current Standards Simplified,” published in July 2004, “A New U.S. National Standard for Medical Devices,” published in September 2006, “Regulatory Strategies for the 3rd ed of IEC 60601-1”, published in September 2009, MEM article “Safety Requirements: Understanding IEC 60601-1,” published in the Fall 2004, CE (Compliance Engineer) articles “Risk Management Implications of IEC 60601-1, 3 Ed.”, “A Regulatory Review of the EMC Standard for Medical Devices”, published January 2005, and Journal of Medical Device Regulation article “IEC 60601-1 - Third Edition” published in May 2006. He has been a member of MD&DI’s Editorial Advisory Board since 2006.