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Posts by Leo Eisner

Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
Establishing a QMS
Etienne Nichols
February 2, 2024

FDA Publishes Final Rule on QMSR

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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Ultimate Guide to ISO 14155:2020 for Medical Devices

Jon Bergsteinsson
September 15, 2023
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About the Author

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.

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Product Development

25 FAQs (& Answers) about ISO 15223-1:2021 Fourth Edition

Leo Eisner
October 31, 2021
In this article you will find a comprehensive list of the most frequently asked questions from participants who attended the Greenlight Guru webinar, Attention ⚠️ ISO 15223-1... Read More

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