Frank O'Brien

Our IEC 60601 safety training instructor, and founder

Summary

  • Since 1980, has evaluated 1000’s of medical electrical equipment for safety, covering a diverse range, including magnetic resonance imaging equipment, left ventricular assist devices, robotically assisted surgical systems, and proton accelerators

  • Since 1996, has helped draft IEC international safety requirements for medical electrical equipment

  • Has trained over over 1,500 participants in IEC/ISO 60601 & 80601 safety requirements

  • Master of Science, SUNY Stony Brook; Bachelor of Science, Clarkson University

  • Lives in County Clare, Ireland; previously Boston, San Jose, Frankfurt, and Long Island, NY

Profesional Experience

O’Brien Compliance Management, LLC

  • Las Vegas, NV, 2018 to present

    • Provide training services to IEC/ISO 60601 & 80601 series of safety standards for medical electrical equipment, and related Risk Management, Usability Engineering, and Software development standards.

  • Chelmsford/Lowell, MA, USA, 2004 to 2018

    • Founded a safety consulting firm providing safety testing and consulting services for medical device manufacturers. Laboratory was accredited by TUV Rheinland for their testing and certification services. Provided public and private training seminars to IEC 60601 series of standards.

Underwriters Laboratories (UL), Inc,

  • Chelmsford, MA, 2001 to 2004

    • Setup a new test laboratory for the medical electrical equipment sector, and obtained IECEE CB Scheme accreditation (international certification body certification).

  • Santa Clara, CA, 1996 to 2001

    • Helped set up testing services to UL 2601, a new standard based on IEC 60601, the international standard for medical electrical equipment; and certification services to the new European Medical Device Directive, 93/42/EEC, coming into effect. Began working on IEC committee TC62, drafting the new 3rd edition of the IEC 60601 standard (series of standards).

  • at VDE Prufstelle, Offenbach am Main, Germany, 1990 to 1996

    • First UL engineer stationed in Europe. Provided training and review of VDE test engineering work to US safety standards for medical equipment, UL 544, and X-ray equipment, UL 187, integrating UL’s certifications into VDE’s certifications to IEC 60601/VDE 0750, the international standard for medical electrical equipment.

  • Melville, NY, 1980 to 1990

    • Provided safety testing and certification services for product manufacturers, in a number of product categories, including medical equipment to UL 544; and X-ray equipment to UL 187.

IEC Committee Work

Since 1996 has participated on IEC TC62 related committees and working groups involved in drafting the general safety requirements and those specializing in Home Health Care Environment, Linear Accelerators, and Robotically Assisted Surgical Equipment

Awards & Licenses

  • 1906 Award recipient, recognizes exceptional achievements of IEC committee experts, 2019

  • Speaker at IEEE safety conferences, and authored numerous articles in safety publications, 2004 to 2014.

  • Professional Engineering License, New York State, 1986

Education

State University of New York (SUNY), Stony Brook, NY, 1990

  • Master of Science, Technology Management

Clarkson University, Potsdam, NY, 1980

  • Bachelor of Science, Electrical and Computer Engineering