Greenlight Guru Medical Device Blog

Leonard (Leo) "The 60601 Guy" Eisner is the head of Eisner Safety Consultants. He is a world renowned IEC 60601 (Medical Electrical Equipment) expert, speaker, and author, and is involved in the development of the IEC 60601 series (on multiple working groups (WGs) and maintenance teams (MTs) including the interpretations WG & worked on IEC 60601-1, edition 3.2), he is the US co-chair of IEC/SC62D (in charge of many of the IEC 60601-2-XX/IEC 80601-2-XX Particular standards), is a member of TC210/WG3 for ISO 15223-1, several Quality System WGs for the US and the CB Scheme ETF-3 RM Group. He has presented with the FDA on the Accreditation Scheme for Conformity Assessment (ASCA) pilot program. Leo and his team have helped countless clients through the Compliance and Regulatory maze over his career, with over 30 years’ experience. Leo has audited for several EU Notified Bodies and has been a technical reviewer on Medical Electrical Equipment and Active Implantables. He is currently working with NSAI.