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BRIAN R. BIERSACH
PERSONAL PROFILE:
Founder and President, Sr. Biomedical Engineer of Medical
Equipment Compliance Associates, LLC (MECA)
• Medical Equipment Compliance Evaluation to
Reference Standard(s)
• Medical Equipment Testing to Reference
Standard(s) or Client's Specifications
- IEC 60601-1, UL 60601-1, EN
60601-1, CSA C22.2 No. 601.1, IEC 60601-1-X Collaterals, IEC
60601-2-XX Particular Standards
- Many ISO, IEC, EN, AAMI, and ANSI
Medical Standards
• Lab Accredited (ISO 17025) by the IECEE (CB
Scheme), Underwriters Laboratories, TUV Rheinland
• 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 Writing
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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PAULA C. BIERSACH
PERSONAL PROFILE:
Accountant, Tax , and Legal for Medical
Equipment Compliance Associates, LLC (MECA)
PREVIOUS WORK HISTORY:
- Senior Auditor and Accountant for major
international Public Accounting Firm
- Held following positions with international
manufacturing company:
- Financial Reporting and
Consolidations Supervisor
- SAP software implementation team
expert and trainer in Accounting/Finance module
- Tax and Legal Compliance Specialist
- Key Budgeting, Planning and
Analysis Team member
- Financial Recruiter for international recruitment firm
- Financial Consultant for international financial and
IT consulting firm
EDUCATION
Bachelor of Business Administration degree - major
in Accounting - University of Wisconsin Milwaukee (UWM)
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