WELCOME TO THE BIERSACHS' WEBSITE


The Biersach Family, 2004

       
 Haley                                                      Jamie


Mirror Sites:  biersach.netbrianbiersach.comskeptismo.comskeptizmo.com


Email                Personal                    Work

Brian Biersach:   brian@biersach.net     bb@60601-1.com

Paula Biersach:   paula@biersach.net    pb@60601-1.com

Jamie Biersach:   jamie@biersach.net

Haley Biersach:   haley@biersach.net
 

 

 

BIOGRAPHIES
 

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)
 

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)
 

JAMIE M. BIERSACH

PERSONAL PROFILE:
 
- N/A
 

HALEY M. BIERSACH

PERSONAL PROFILE:
 
- N/A