Leonard Eisner

About Leonard Eisner

I am the founder and principal compliance and regulatory consultant of Eisner Safety Consultants, we provide the medical device industry with product safety compliance & regulatory support.I ensure my clients’ medical device compliance needs are met with uncompromising attention to detail and quality. I provide my clients with practical assessments of their product(s) and provide strategies & support to help them through the medical device product compliance maze.As an expert in the standards development process, I have been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 204171. Provided expertise to 100’s of SMEs and Fortune 500 companies for successful medical device compliance projects2. Reviewed/generated 30+ product safety and labeling/marking sections of EU technical file/technical documentation (MDD/MDR)/ DHF for active medical devices and active medical implantables3. Expert Member of development teams on IEC 60601-1, edition 3.2 (via IEC TC62/SC 62A/MT28 & MT30 & WG14 & IEC TC62A/Ad Hoc Group 62••••••01) and 4th edition of IEC 60601-1 - Working Groups assignments in process currently - https://bit.ly/IEC60601-1FourthEdTimeToGetInvolvedIsNOW

Experience

1. Committee Member Tc 210 Wg2 Gen Asp Fr Appl of Qlty Princ Med Dvcs

   Iso - International Organization For Standardization

   Apr 2023 — Present

   General aspects stemming from the application of quality principles to medical devices

Education

• Santa Clara University

  Master of Business Administration - MBA, Business Administration and Management, General

  1989 — 1993

• San José State University

  BSEE, Electrical Engineering

  1980 — 1985

Skills

• Iso
• Cmdr
• Fda
• Regulatory Strategy Development
• Product Certification
• Internal Auditing Medical Device Quality Systems
• Standardization
• 21 Cfr
• Iso 13485
• Iec 60601
• Product Development
• Cmdcas
• U.s. Food and Drug Administration (Fda)
• Quality System
• Quality Systems
• Regulatory Requirements
• Testing
• Regulatory Documentation
• Regulatory Submissions
• Fda Gmp
• Standards Development
• Standards Compliance
• Eu
• Quality System Compliance
• Iec 60601-1 Series of Standards
• Ce Marking
• Cenelec
• Cross-Functional Team Leadership
• Supplier Quality
• Iso 14971
• Mdd
• European Union
• Medical Devices
• Iso 9000
• Technical Files
• Medical Device Directive
• Fda Quality System Regulation
• Regulations
• International Standards
• Quality Management