Profile

Leonard Eisner, MBA, PE

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Bio

Leonard (Leo) Eisner is principal medical device product safety, regulatory, and quality systems consultant at Eisner Safety Consultants. His focus is on active medical equipment (IEC 60601 series). He routinely speaks and writes as an international expert on the topic of IEC 60601 series. He is heavily involved in the standards development process of the IEC 60601 series. He is the US co-chair of IEC SC 62D, a committee member of IEC TC 62, SC 62A & SC62D, and multiple working groups and maintenance teams working on the next version of IEC 60601-1. He has over 30 years experience in product safety. He is the manager of the LinkedIn discussion group IEC 60601 Series – Medical Electrical Equipment.

Education

San Jose State University
BSEE
1980 To 1985

Year Entered Profession

  • 1985-1989

Current Organization Type

  • Consulting Firm

Job History

Principal Consultant
May 1997 - present

Compliance Engineer
June 1996 - September 1998

Senior Product Safety Engineer
July 1994 - May 1996

Engineerign Group Leader
July 1985 - June 1994

Highest Degree Earned

  • Masters

Regional Interests

  • Africa
  • Brazil
  • Canada
  • China
  • Europe
  • Japan
  • Latin America/Carribean
  • Middle East
  • US
  • Worldwide

Product Interests

  • Biotechnology
  • Combination Products
  • IVDs
  • Medical Devices