Leonard Eisner is a founder and principal consultant at Eisner Safety Consultants who specializes in helping medical device manufacturers through product safety, international regulatory (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.) and quality system processes.
Assistance to clients is provided with a team of experts in the interface with the Safety Agencies and Regulatory Bodies, preparing the product for testing, support is also provided in many aspects to obtain FDA 510(k) approval, CE Marking and CMDR including preparation of technical files, training on the product safety standards, directives and quality standards, risk management, assisting companies in developing international standards, and creation and implementation of quality systems.
Leo is a licensed professional engineer in safety engineering, a Notified Body and Quality System auditor/technical reviewer, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives. Leo has helped countless clients thru the Product Safety and Regulatory maze over his career. He has 30 years experience in product safety. Leo ran the Compliance Engineering Group at Karl Storz and was a Senior Product Safety engineer at TÜV Product Service. Prior to that Leo worked in a cross section of groups at U.L. for 9 years. Leo is very active in the standards development world.
Leo's focus is on active medical electrical equipment including home use and wearable devices. He is the US co-chair of IEC SC62D (majority of IEC 60601-2-xx standards), convener of IEC SC62D JWG9 (IEC/ISO 80601-2-58) and a committee member of US TAG (which includes International Involvement in IEC) for TC62, SC62A, SC62D, & SyC AAL (Active Assisted Living System Committee - Home use medical and non-medical devices). 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) and is currently involved in the development of IEC 60601-1, 3rd edition + Amendment 2 and will also be involved in the development of the 4th edition thru SC62A MT 28 (Electrical Hazards), SC62A MT30 (Thermal Hazards), and SC62A WG14 (60601-1 Interpretations).
He is a member of the Chairman's advisory group (CAG) on IEC SC62D. Leo is a member of the AAMI committee for Home Use Medical Devices/Emergency Medical Devices Services (and the corresponding IEC SC62A/JWG's 6 & 8 which are for the Home Use & Emergency Medical Services Environments respectively). And the list of his standards involvement goes on.
Leo is a member of RAPS, AAMI, ASQ, IEEE (& IEEE EMBS), and the Oregon Bioscience Association. He is the manager of the LinkedIn discussion group IEC 60601 Series - Medical Electrical Equipment. Leo was a member of the MD&DI Editorial Advisory board until recently disbanded.
Leo is an advisor to BSI on a series of Medical Device White Papers and is assisting BSI as a reviewer and author of Expert Commentary on recently released medical device standards for BSI’s Compliance Navigator system (Standards Monitoring & Update Service among other features). Leo has presented trainings and workshops in many forums to help understand the current and future requirements around 60601-1 and its’ series of the standard.
Leo is the author of a long list of articles & white papers for MD&DI, InCompliance CE (Compliance Engineer), Journal of Medical Device Regulation, etc. on various IEC 60601, medical device, and home use medical & wellness device topics. He actively provides editors of medical device journals material on IEC 60601-1 and has a blog that provides up to date information on medical device product safety, regulatory and quality system issues.