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IEC 60601-1
Medical Equipment Compliance,
Certification, and Regulatory Services and Information

Medical Equipment Compliance Associates, LLC

MECA Team Biographies

Brian Biersach
President, Sr. Biomedical Engineer
Founder of Medical Equipment Compliance Associates, LLC in 2002

MECA
- Evaluation of medical equipment to IEC 60601-1, with Collateral and Particular standards
- Presentation of seminars and client training on the IEC 60601-1 medical standards
- Compliance Report documentation

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

PRIOR TO FOUNDING MECA
Underwriters Laboratories Inc.: Medical Device Services Reviewer and Project Engineer
- Evaluation, testing, and documentation of medical equipment to medical standards
- Primary instructor for UL's UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
- ISO9000 and EN46001 Quality Systems Auditor in Training
- Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program

STANDARDS COMMITTEES
AAMI - IEC SC 62A WG14 (Interpretations and Testing to the '60601 Medical Standards)
AAMI - IEC SC 62A PT 62354 (General Testing Procedures for Medical Electrical Equipment)
AAMI - IEC/ISO SC 62D JWG4 (Medical Beds)

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

Jeremi Peck
Vice President, Sr. Biomedical Engineer

MECA
- Evaluation of medical equipment to IEC 60601-1, with Collateral and Particular standards
- Evaluation of laboratory equipment to IEC 61010-1, with Particular standards
- Presentation of seminars and client training on the UL/IEC 60601-1 medical standards
- Compliance Report documentation

EDUCATION
Milwaukee School of Engineering (MSOE): BS degree in Biomedical Engineering

PRIOR TO MECA
Underwriters Laboratories Inc., Technical Manager and Primary Reviewer for Medical Device Services
- Evaluation, full testing, and documentation of medical equipment to UL, IEC, EN, and CSA medical standards
- Primary instructor for UL's UL, IEC, EN 60601-1, and IEC 60601-1-4 technical seminars and workshops
- Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
- Technical Expert for Healthcare Electrical Systems per NFPA 70 and NFPA 99
- Technical Expert for European Medical Device Directive (93/42/EEC)

PUBLISHED
2010-01: Chapter 3: 2010-01 Elsevier Inc. Text Book

Alex Grob
Chief Biomedical Engineer

MECA
- Evaluation of medical equipment to IEC 60601-1, with Collateral and Particular standards
- Evaluation of laboratory equipment to IEC 61010-1, with Particular standards
- Compliance Report documentation
- Lead Risk Management reviewer
- Presentation of seminars and training on ISO 13485, ISO 14971 and the IEC/UL/CSA/EN 60601-1 standards
- Quality Manager for IEC/ISO 17025 laboratory quality system
- Lead Auditor (ISO 9001 & ISO 13485)
- Technical Expert for European Medical Device Directive (93/42/EEC) Audits (for CE Marking)

EDUCATION
Milwaukee School of Engineering (MSOE): BS degree in Biomedical Engineering

PRIOR TO MECA
GE Healthcare: Director, Regulatory Affairs - Standards
- Responsible for defining & implementing internal process & tools for the identification of global standards requirements
- Primary technical resource for interpreting standards and their relationship to global regulations
- Develop and present standards related training for employees
Underwriters Laboratories Inc.: Medical Device Services Reviewer and Sr. Project Engineer/Quality System Auditor
- Evaluation, testing, and documentation of medical equipment to UL, IEC, EN, and CSA medical & laboratory equipment standards
- Primary instructor for UL's UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
- ISO 9000/ISO 13485, CMDCAS, FDA Accredited Persons Inspection Program and EU MDD Annex II/IV Quality Systems Auditor
- Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program at Underwriters Laboratories

STANDARDS COMMITTEES
- CO-CHAIR of AAMI Electrical Safety Committee
- IECEE MEE Task Force (for IEC 60601-1 Risk Management)
- IEC SC 62A MT 28 (IEC 60601-1 Electrical hazards)
- AAMI CSS, AAMI ES

Robert Koch
Compliance Engineer

MECA
- Medical Equipment testing
- Alarm Systems Expert
- Compliance Report Documentation
- Development of test fixtures and processes

EDUCATION
DeVry University: Magna Cum Laude BS Degree in Electrical Engineering Technology

PRIOR TO MECA
Baxter: Laboratory Technician
Underwriters Laboratories, Inc.: Project Handler

STANDARDS COMMITTEES
- AAMI Medical Device Alarms Committee

Justin Martineau
Sr. Biomedical Engineer

MECA
- Evaluation of medical equipment to IEC 60601-1, with Collateral and Particular standards
- Medical Equipment testing
- Compliance Report documentation
- Client project interaction
- Lab Coordinator

EDUCATION
Milwaukee School of Engineering (MSOE): BS degree in Biomedical Engineering

Cathi Koch
Account Executive, Quality Manager

MECA
- Quality Manager
- Project management and scheduling
- Quote generation, management
- Client project communication

PRIOR TO MECA
Naval Station Great Lakes
- Personnel Assistant at Center for EOD and Navy Divers
- Leave Administrator at Center for Naval Engineering, Great Lakes
CVS/Caremark
- IT Training Assistant