Leonard (Leo) Eisner is the head of Eisner Safety Consultants. He is a licensed professional engineer in safety engineering, a certified Quality System lead auditor, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device directive. Leo Eisner helped countless clients thru the Product Safety and Regulatory maze over his career. He has over 30 years experience in product safety/compliance. Leo ran the Compliance Engineering Group at Karl Storz & was a Senior Product Safety engineer at TÜV Product Service. Leo has audited for several EU Notified Bodies and has been a technical reviewer on Medical Electrical Equipment.
Standards Development Work by Leo Eisner
Leo Eisner is heavily involved in the standards development world. He is currently working on the development of Amendment 2 of IEC 60601-1, 3rd edition as a member of TC 62/SC 62A/WG 14, MT28 & MT 30. Leo is involved in the update for IEC 60601-1-11 as a member of IEC SC62A/JWG 6. He will be involved in the development of IEC 60601-1, 4th edition. If you want to see more detail about Leo’s extensive standards involvement & work click here.
Leo Eisner is a technical advisor & expert reviewer to BSI on a series of Medical Device White Papers that have been published starting in 2014 and he continues to support this effort. Leo is a reviewer and author of Expert Commentary on recently released medical device standards in the EN/IEC 60601 series of standards for BSI’s Compliance Navigator Service.
Leo Eisner has been a long-time member of the MD&DI Editorial Advisory board til recently disbanded in late 2016. Leo has authored many articles on IEC 60601, Home Use Medical Devices & FDA Guidances related to Electrical Medical Devices for MD&DI, InCompliance, Informa, MEM, Compliance Engineer, & Journal of Medical Device Regulation.
Leo is the manager of a LinkedIn Group – IEC 60601 Series – Medical Electrical Equipment.
Leo will also be speaking at Medical Device Academy’s 510(k) workshop in Amsterdam on October 11-12, 2017.
More details about Leo Eisner
He is a co-chair of the U.S. TAG (technical advisory group) for IEC/SC 62D, 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) & SC 62D (Electromedical equipment). Leo is on the AAMI Electrical Safety (ES) Committee, which develops the US version of the IEC 60601-1 standard (ANSI/AAMI ES 60601-1). He is the convener of SC62D JWG9 “Lens removal and vitrectomy devices for ophthalmic surgery” and is a member of the Chairman’s advisory group (CAG) for IEC SC62D. Leo is a member of the SC 62A/WG 14 (Testing to General Safety Standard – The Working Group is chartered to develop recommendations regarding interpretation & application of IEC 60601-1), SC 62A/MT 30 (Overheating, fire protection and additional hazards) & SC 62A/MT 28 (Electrical Hazards).
To support the increase in demand for Home Use medical devices and Wearables Leo is a member of the AAMI (US TAG) & IEC committees for Home Use Medical Devices/Emergency Medical Devices Services (IEC SC62A/JWG’s 6 & 8) and member of the ANSI (US TAG) & IEC committee for Active Assisted Living SyC (System Committee approach for an aging population, their families & care provides with solutions that enable them to live longer but also to live a better life at home instead in a hospital or nursing home or other clinical setting). Leo is also a member of the AAL SyC WG4 (Regulatory Affairs at the national & regional levels of regulators on AAL) & WG3 (Quality & Conformance). Additionally, Leo is a member of Project Team 60050-871 to develop a common AAL vocabulary/terminology and a member of CAG’s 1 & 2.
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