Medical Device Link.

EDITORIAL ADVISORY BOARD

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. Mr. Eisner 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 more than 23 years of experience in the product safety arena. He worked at UL for nine 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, where he worked for more than two years as a compliance engineer. Mr. Eisner has been consulting for 10 years in product safety, quality systems, standards development, CMDR, and CE marking. He 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.” He is a member of RAPS, AAMI, ASQ, and IEEE. He is a coauthor of several MD&DI articles, including: “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; and “A New U.S. National Standard for Medical Devices,” published in September 2006. Other articles include “Safety Requirements: Understanding IEC 60601-1,” published in the Fall 2004 issue of Medical Electronics Manufacturing. He has been a member of MD&DI’s Editorial Advisory Board since 2006.

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