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Leo Eisner

Leonard (Leo) Eisner is principal medical device product safety and regulatory consultant at Eisner Safety Consultants. Eisner’s focus is on medical electrical equipment (IEC 60601 series). He has over 30 years’ experience in product safety. Eisner routinely speaks and writes as an international expert on the topic of IEC 60601 series. He is a committee member of IEC TC 62, SC 62A & SC62D, is a U.S. co-chair of SC62D, and actively involved in the development of IEC 60601-1 edition 3.2 (draft) and the discussions on the architecture of 4th edition. Eisner is the manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.

From This Author

The IEC 60601 Amendment Updates Have Published: Changes and Impacts

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.

The Future of the IEC 60601 Series: An Update

This article discusses where we are currently with the IEC 60601 series of standards and where we are headed for the next round of amendments (2020 - 2022). Further down the line is the development of the next full edition of the IEC 60601 Series (targeting around 2024 publication).

The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?

This article discusses the history of why the EU MDR came into existence. It goes into the critical dates to be aware of, many of the significant changes, and impacts on many of the players (Notified Bodies, manufacturers, etc.). Lastly, it details the key steps that device manufacturers should take to implement the provisions of the MDR.

How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World

This article focuses on medical electrical devices and three countries/regions of the world, the U.S., Canada and the European Union (EU). There are a lot of regulatory, quality system and standards changes happening in the medical device space in the last couple years and these will continue in the years ahead.

Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents

This article will focus on the U.S. Food and Drug Administration’s guidance documents and the standards applicable to wearable medical and wellness devices.
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