
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.
The IEC 60601 Amendment Updates Have Published: Changes and Impacts
The Future of the IEC 60601 Series: An Update
The EU’s Medical Device Regulation (EU) 2017/745 – Are You Ready for Huge Sweeping Changes?
How to Stay Up to Date on The Ever-Changing Landscape of the Medical Electrical Device Regulatory World
Wearables for Medical and Wellness Uses: Standards and FDA Guidance Documents
Home Use Medical and Wellness Devices