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- Speed Your Medical Equipment to Market -
     
     
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MECA BACKGROUND |
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MECA was formed to assist medical companies with their safety
certification, compliance, and regulatory needs, including compliance
assistance in the design and development phase, compliance evaluation
and reports, safety certification, and global regulatory support.
We have grown our business and network of associates with the leaders
in their respective fields, to offer complete the highest level of
certification and regulatory support.
We are honored to service 6
of the Top 10 Medical Manufacturers Worldwide
(13 of the Top 40) as clients (per
MD&DI - December, 2011 Ranking) |
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MECA QUALITY SYSTEM and THIRD PARTY PROGRAMS |
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MECA has an ISO 17025 compliant Quality System (for
Calibration and Testing Labs) .
We are under the CB Scheme,
as an ACTL (Associated CB Testing Laboratory) for the Medical
Category (Audited to ISO 17025)
IECEE Website Page for
MECA: IECEE
CB Scheme - MECA
MECA's IECEE audit was conducted successfully on March
28th, 2011.
We are awaiting the processing of our updated 3 Year
certificate (which takes 6 to 9 months, based on previous audits).
Until the new certificate is provided, the following
extension certificate was issued.
Since the extension certificate has also now expired,
and we have not yet received the new IECEE certificate from the
March, 2011 audit, the following Notarized Document has been
generated to support our continued compliance with the IECEE CB
Scheme requirements.
As soon as we receive the new 3-year Certificate, we
will provide it here.
We are under the UL
Third Party Test Data Program for the Medical
Category (Audited to ISO 17025)
(2012 Certificate currently being generated by UL)
We under the TUV
Rheinland Qualified Laboratory Program for the Medical
Category (Audited to ISO 17025)
(2012 Certificate currently being generated by TUV)
Quality Policy Statement:
Ensure accurate and timely Compliance Evaluations,
Testing, Compliance Engineering Services, and Training; as well as
continuously meet or exceed the stated or implied expectations of our
clients, through day-to-day interactions.
a) Management is committed to good professional
practice and quality of services provided to the client.
b) Testing is always carried out in accordance with
stated standardized methods and customers' requirements. Requests to
perform tests that may jeopardize an objective result or have a low
validity are rejected.
c) Standards of service include Customer
Satisfaction, Accuracy, and Timeliness. Excellence in the workplace
is promoted by providing all employees with the knowledge, training,
and tools necessary to allow for the completion of accurate and
timely work.
d) The purpose of the management system, as it
relates to quality, is to manage our business by meeting the
needs of our customers.
d) Personnel shall be familiar with quality
documentation and implement the policies and procedures in their work.
e) Management is committed to complying with ISO
17025 and ISO 9001 international standards and to continually improve
the effectiveness of the management system.
The objective of the MECA Quality Manual is to
document the compliant policies and associated procedures that are
integrated into our daily activities. Continual improvements are
established, implemented, and locked into the quality system.
Additional objectives include:
- Establish the level of the laboratory's
performance/efficiency, and make changes to improve it
- Participate in proficiency testing or quality
evaluation programs with third party or peer laboratories
- Improve and validate laboratory methodologies by
participation in method validation collaborative tests, where applicable
- Ensure that all personnel are trained to a level
of familiarity with the quality management system appropriate to the
individual's degree of responsibility |
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Brian R. Biersach - President, Sr. Biomedical Engineer |
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Founder of Medical Equipment Compliance Associates, LLC (2002)
MECA
- Evaluation of medical equipment to IEC/UL/CSA/EN 60601-1, with
Collateral and Particular standards
- Presentation of seminars and client training on the IEC/UL/CSA/EN
60601-1 medical standards
- US expert for IEC, ISO, AAMI Working Groups for
International medical standards writing
- Technical Expert for European Medical Device Directive
(93/42/EEC) Audits (for CE Marking)
- Present seminars and provided training for AAMI (Association for
the Advancement of Medical Instrumentation)
- Published in Medical Device & Diagnostic Industry (March, 2003)
- Published in IEEE Instrumentation (December, 2003)
- Published in Mission-Critical and Safety-Critical Systems Handbook
(Chapter 3) (2010 Elsevier Inc. Text Book)
EDUCATION
MSOE: BS degree in Biomedical Engineering
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 UL,
IEC, EN, and CSA 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 at Underwriters Laboratories |
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AAMI / IEC / ISO Standards Committees:
 AAMI
- IEC SC 62A WG14  AAMI
- IEC/ISO SC 62D JWG4 |
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Published:
(2003-12 IEEE Published Article) 
(2003-03 MD&DI Published Article) 
(Chapter 3: 2010-01 Elsevier Inc. Text Book) |
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Jeremi M. Peck - Vice President, Sr. Biomedical Engineer |
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MECA
- Evaluation of medical equipment to UL/IEC 60601-1, with Collateral
and Particular standards
- Presentation of seminars and client training on the UL/IEC 60601-1
medical standards
- Published in Mission-Critical and Safety-Critical Systems Handbook
(Chapter 3) (2010 Elsevier Inc. Text Book)
EDUCATION
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 60601-1, IEC 60601-1, 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) |
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(Chapter 3: 2010-01 Elsevier Inc. Text Book)
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Alex Grob - Chief Biomedical Engineer |
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MECA
- Evaluation of medical equipment to IEC/UL/CSA/EN 60601-1, with
Collateral and Particular standards
- Presentation of seminars and client training on ISO 13485, ISO
14971 and the IEC/UL/CSA/EN 60601-1 series of medical standards
- Expert on National (AAMI) and International (IEC) Working Groups
for medical standards writing
- Lead Auditor (ISO 9001 & ISO 13485)
- Technical Expert for European Medical Device Directive (93/42/EEC)
Audits (for CE Marking)
EDUCATION
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 |
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Jim Wismar - Senior Project Engineer |
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MECA
- Evaluation of medical equipment to UL/IEC 60601-1, with Collateral
and Particular standards
- Presentation of seminars and client training on the UL/IEC 60601-1
medical standards
EDUCATION
MI Tech: BS degree in Electrical Engineering
PRIOR TO MECA
Smiths Medical: Patient Monitoring Regulatory and Test Engineer
- Standards expert and test manager for R&D of patient monitors
with emphasis on 60601-2-49, -27, -30, -34; 9919 and 21647.
- Technical File, 510(k) generation and update
- Risk management, IRB, software testing
Underwriters Laboratories Inc.: Project Engineer for life
safety products
- Evaluation, full testing, and documentation of equipment to
appropriate standards |
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Certs to be added |
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Robert Koch - Engineering Technician |
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MECA
- Medical Equipment testing
- Compliance Report Documentation
- Test Fixture construction
EDUCATION
DeVry University: BS Degree in EET
Prior to MECA
Baxter: Laboratory Technician
Underwriters Laboratories, Inc.: Project Handler |
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Paul Dillon - Engineering Technician |
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MECA
- Medical Equipment testing
- Development of test fixtures and processes
EDUCATION
Herzing University: BS Degree in EET
MATC: Broadcast Engineering
University of Phoenix: Business Management
PRIOR TO MECA
GE Healthcare: Compliance Test Engineer
- Senior Engineering Technician
Marquette Medical Systems: Engineering Technician
- Field Service Technician
- Electronic Technician |
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Certs to be added |
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Alex Preston - Engineering Assistant |
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MECA
- Client project interaction
- Project scheduling
- Compliance Report documentation
- Medical Equipment testing
EDUCATION
Gateway Technical College: EET Student |
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Anna Herzfeld - Engineering Assistant |
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MECA
- Client project interaction
- Project scheduling
- Compliance Report documentation
- Medical Equipment testing
EDUCATION
Marquette University: Biomedical Engineering Student |
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N/A |
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Paula C. Biersach - Vice President of Finance |
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MECA
- Accounting
- Tax and Legal
EDUCATION
UWM: Bachelor of Business Administration degree - major in Accounting
PRIOR TO MECA
Major International Public Accounting Firm: Senior Auditor and Accountant
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
International Recruitment Firm: Financial Recruiter
International Financial and IT Consulting Firm: Financial Consultant |
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Rachel Tift - Engineering Assistant |
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2011 Summer Engineering Intern |
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N/A |
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