About

BRIAN R. BIERSACH

 

PERSONAL PROFILE:

President, Sr. Biomedical Engineer of Medical Equipment Compliance Associates, LLC  (MECA)
• Founded company in 2002

• Medical Equipment Compliance Evaluation to Reference Standard(s)

• Medical Equipment Testing to Reference Standard(s) or Client's Specifications

    - IEC 60601-1, AAMI ES 60601-1, EN 60601-1, CSA C22.2 No. 60601-1
    - IEC 60601-1-X Collaterals, IEC 60601-2-XX Particular Standards

    - Many other ISO, IEC, EN, AAMI, and ANSI Medical Standards

• Partial and Total Compliance Outsourcing Services

• Compliance Engineering Services

• Training and Seminars on Medical Standards and Compliance-Related Topics

• US Technical Expert for AAMI on IEC/ISO Working Group Committees for international medical Standards

• Lab Accredited to ISO 17025
    - A2LA Accredited Testng Laboratory, with ilac MOU
    - IECEE (CB Scheme) Testing Laboratory
    - Underwriters Laboratories (UL) Testing Laboratory
    - TUV Rheinland Testing Laboratory
    - Intertek (ETL) Testing Laboratory

 

PREVIOUS WORK HISTORY:

Medical Project Engineer and reviewer for Underwriters Laboratories Inc. (UL)

- Provided conformity assessment and safety certification of medical Electrical Equipment to
  UL2601-1, EN60601-1, IEC60601-1 with all Collateral and Particular Standards

- Instructor for UL's IEC 60601-1, EN 60601-1, UL 2601-1 technical seminars and workshops

- Prepared UL and CB-Scheme Reports and test data packages with multinational deviations
  for medical electrical equipment

- Provided FDA 510(k) reviews of eligible medical devices, under the FDA Third Party Review Program

- Technical Expert  for European Medical Device Directive (93/42/EEC) Audits (CE Marking)

- ISO9000 and EN46001 Quality Systems Auditor

 

EDUCATION

BS in Biomedical Engineering - Milwaukee School of Engineering (MSOE)

BA in Economics, Minor in Anthropology - University of Wisconsin Milwaukee (UWM)

 

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