Brian Biersach

Brian Biersach

Founder of Medical Equipment Compliance Associates, LLC in 2002

  • Technical expert for the medical IEC 60601-1 series of standards
  • Technical expert for the risk management and software process standards
  • Evaluation and testing of medical equipment to IEC 60601-1 series of standards
  • Development of test fixtures and processes
  • Training and seminars on the medical standards

EDUCATION

Milwaukee School of Engineering (MSOE): BS in Biomedical Engineering
University of Wisconsin, Milwaukee (UWM): BA in Economics, Minor in Anthropology

STANDARDS COMMITTEES

  • US Expert for IEC SC 62A WG14 (Interpretations and Testing to the ‘60601 Medical Standards)
  • US Expert for IEC SC 62A PT 62354 (General Testing Procedures for Medical Electrical Equipment)
  • US Expert for IEC/ISO SC 62D JWG4 (Medical Beds)

PUBLISHED

2014: WMDO International Web-based Seminar on IEC 60601-1, Edition 3.1
2010-01: Chapter 3: 2010-01 Elsevier Inc. Text Book
2003-12: IEEE Published Article
2003-03: MD&DI Published Article

PRIOR TO MECA

Underwriters Laboratories Inc.: Medical Device Services Reviewer and Project Engineer

  • Evaluation of medical equipment to international standards
  • Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
  • Primary Instructor for UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
  • ISO9000 and EN46001 Quality Systems Auditor in Training

ABOUT

Since founding MECA in 2002, Brian has been working with clients to help them understand and meet the ever-increasing complexity of medical device standards requirements. In addition to handling full medical device evaluation projects, he enjoys creating guidance documents to help streamline the evaluation process and building test fixtures for the lab. Outside of work, Brian enjoys traveling and watching good sci-fi movies. He has also been seen at Comic Con a few times with his two daughters.

2019-06-27T21:34:31+00:00March 26th, 2019|

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