Maintenance:
Blog Manager: 60601-1.blogspot.com
MECA Websites (1and1.com):
MedicalEquipmentComplianceAssociates.com
Biersach Web Addresses (1and1.com):
About Us
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)
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 in Accounting - University of Wisconsin Milwaukee (UWM)
PHOTOS/VIDEOS
contact
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
Copyright. All Rights Reserved 2014.