- Speed Your Medical Equipment to Market - MECA BACKGROUND MECA was formed to assist medical companies with their safety certification, compliance, and regulatory needs, including design, development, safety certification, and global regulatory support. We have grown our network of associates who are the leaders in their respective fields to offer complete certification and regulatory support. We are honored to service 7 of the Top 10 Medical Manufacturers Worldwide (17 of the Top 40) as clients (per MD&DI - December, 2009 Ranking)   MECA QUALITY SYSTEM and THIRD PARTY PROGRAMS MECA has an ISO 17025 (and by default, ISO 9000) compliant quality system. We are under the CB Scheme, as an ACTL (Associated CB Testing Laboratory) for the Medical Category MECA Scope: CB Scheme MECA Scope We are under the UL Third Party Test Data Program We are a TUV Rheinland Qualified Laboratory, under the Partner Test Laboratory Program   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   BIOGRAPHIES Brian R. Biersach - President, Sr. Biomedical Engineer Founder of Medical Equipment Compliance Associates, LLC BS degree in Biomedical Engineering (MSOE) BA degree in Economics (UWM) - 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 AAMI on IEC / ISO 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) 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  AAMI / IEC / ISO Standards Committees:   AAMI - IEC SC 62A WG14  AAMI - IEC/ISO SC 62D JWG4 Published:   (2003-12 IEEE Published Article)  (2003-03 MD&DI Published Article)  (2010-01 Elsevier Inc. Text Book) Jeremi M. Peck - Vice President, Sr. Biomedical Engineer BS degree in Biomedical Engineering (MSOE) - 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) 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)   (2010-01 Elsevier Inc. Text Book)   Jim Wismar - Senior Project Engineer Photo to be added BS degree in Electrical Engineering (MI Tech) - 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 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 medical standards Certs to be added Paula C. Biersach - Vice President of Finance Bachelor of Business Administration degree - major in Accounting (UWM) - Accountant - Tax and Legal  Prior to MECA - Senior Auditor and Accountant for major international Public Accounting Firm - 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     Heidi N. Kramer - Sr. Account Executive - Bachelor of Business Administration (UWM) - Project Management - Report documentation for UL, CB, and Informative Test Reports - Development of medical equipment evaluation templates and tools - Administrative support Prior to MECA - Coordinated corporate ID marketing programs, promotions, and incentive programs for marketing firm - Developed and coordinated internal and external marketing communication documents for marketing firm - Managed Accounts Payable and Receivable for $20+MM in sales Paul Dillon - Engineering Technician EET Degree (Herzing University), Broadcast Engineering (MATC), Business Management (University of Phoenix) - Medical Equipment testing - Development of test fixtures and processes Prior to MECA - Compliance Test Engineer at GE Healthcare - Senior Engineering Technician at GE Healthcare - Engineering Technician at Marquette Medical Systems - Field Service Technician at Marquette Medical Systems - Electronic Technician at Marquette Electronics Certs to be added