Our Team

Founder of Medical Equipment Compliance Associates, LLC in 2002

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Development of test fixtures and processes
• Training and seminars on medical standards

EDUCATION

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

STANDARDS COMMITTEES

• US Expert for IEC SC 62A WG44 (IEC 60601-1, 4th Edition Working Group for Thermal and Fire Hazards)
• US Expert for IEC SC 62A WG14 (Interpretations and Testing to the ‘60601 Medical Standards)
• US Expert for IEC SC 62A PT 62354 (General Testing Procedures for Medical Electrical Equipment)
• US Expert for IEC/ISO SC 62D JWG4 (Medical Beds)

PUBLISHED

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

PRIOR TO MECA

Underwriters Laboratories Inc.: Medical Device Services Reviewer and Project Engineer

• Evaluation of medical equipment to international standards
• Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
• Primary Instructor for UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
• ISO9000 and EN46001 Quality Systems Auditor in Training

ABOUT

Since founding MECA in 2002, Brian has been working with clients to help them understand and meet the ever-increasing complexity of medical device standards requirements. In addition to handling full medical device evaluation projects, he enjoys creating guidance documents to help streamline the evaluation process and building test fixtures for the lab. Outside of work, Brian enjoys traveling and watching good sci-fi movies. He has also been seen at Comic Con a few times with his two daughters.

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for the laboratory equipment IEC 61010-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Evaluation and testing of laboratory equipment to the IEC 61010-1 series of standards
• Training and seminars on medical standards

EDUCATION

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

IECEE CB SCHEME

• Technical Expert – Member of IECEE CTL ETF 17 (MED – Medical Electrical Equipment)
• Technical Expert – Member of IECEE CTL ETF 03 (MEAS – Laboratory, Test, and Measurement Equipment)

PUBLISHED

2010-01: Chapter 3: 2010-01 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
• Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
• Primary Instructor for UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
• Technical Expert for European Medical Device Directive (93/42/EEC)
• Technical Expert for Healthcare Electrical Systems per NFPA 70 and NFPA 99

ABOUT

As co-owner of MECA and VP since 2004, Jeremi has facilitated its growth into the top medical device testing lab in the industry. He is a down‑to‑earth problem solver who enjoys working with people and finding practical ways to get things done. He brings a calm, steady approach to challenges and communicates with clarity and purpose. As a husband and father to two boys, he understands that diplomacy and discussion not only help in his life outside the lab, it provides him with the expertise to engage and partner with clients as he guides them through the complicated compliance process. When he’s away from the business, you’ll usually find him outside fishing or golfing with his sons, boating, traveling with his wife, or doing pretty much anything that gets him outdoors.

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for the laboratory equipment IEC 61010-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Evaluation and testing of laboratory equipment to the IEC 61010-1 series of standards
• Training and seminars on medical standards

EDUCATION

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

STANDARDS ENGAGEMENT

• US Expert for IEC SC 62A WG 42 Co-Convener (IEC 60601-1 Electrical hazards)
• US Expert for IEC SC 62A AG 33 (Chair’s Advisory Group)
• US Expert for IEC SC 62A AG 50 (IEC 60601-1 4^th Edition Editing Team)
• CO-CHAIR of AAMI ES (Electrical Safety) Committee, (responsible for AAMI ES 60601-1)
• Contributing Author, AAMI CR 500 (Basic Introduction to the IEC 60601 Series); AAMI CR 507 (Basic Safety of Emergency Use Medical Devices)

PRIOR TO MECA

GE Healthcare: Director, Regulatory Affairs – Standards

• • Defining & implementing internal processes & 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, full testing, and documentation of medical equipment to UL, IEC, EN, and CSA medical standards
• Accredited FDA 510(k) Reviewer, under the FDA Third Party Review Program
• Primary Instructor for UL 2601-1, IEC 60601-1, EN 60601-1 technical seminars and workshops
• Technical Expert for European Medical Device Directive (93/42/EEC) Audits (for CE Marking)
• ISO 9000/ISO 13485, CMDCAS, and EU MDD Annex II/IV Quality Systems Auditor

ABOUT

Alex is a biomedical engineer that has been working in the medical field for the last 25+ years. Alex has experience as a quality system auditor, 3rd Party 501K reviewer, notified body auditor & technical assessor, testing laboratory engineer, regulator affairs director and is currently the Chief Biomedical Engineer & Quality manager at MECA. Alex is involved in the standards development process for the IEC 60601-1 Series as well as the Co-chair of AAMI-ES, these committees are responsible the US adoption ANSI/AAMI ES 60601-1.

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for the laboratory equipment IEC 61010-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Evaluation and testing of laboratory equipment to the IEC 61010-1 series of standards
• Training and seminars on medical standards
• Laboratory manager

EDUCATION

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

ABOUT

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Training and seminars on medical standards
• Business planning

EDUCATION

Milwaukee School of Engineering (MSOE): BS in Biomedical Engineering, Minor in Mathematics
Milwaukee School of Engineering (MSOE): MBA

STANDARDS COMMITTEES

• IEC 60601-1 4th Edition – TC 62/SC 62A/WG 39: User interface hazards

ABOUT

Since Aly was young, she had a passion for learning how things worked, problem solving and helping people. To her, Biomedical Engineering provides an opportunity to utilize her natural curiosity and apply her technical knowledge in an impactful way. She started her career in engineering before graduating from MSOE as an intern at MECA not one summer, but two! She also spent a summer exploring how Computational Fluid Dynamics (CFD) software and Additive Manufacturing can be used to improve treatment of brain aneurysms. Despite experiencing multiple knee injuries, Aly was a member of the MSOE Women’s soccer team throughout her undergrad and graduate years. Aly’s experiences traveling and exploring the world has given her an appreciation for the delicate balance between humanity and advancing technology and how innovation can bring about changes to how we treat illness. When she’s not at work, you’ll find her camping with her family, going to the gym, taking motorcycle rides, or traveling to explore new sights.

• Technical expert for the medical IEC 60601-1 series of standards
• Technical expert for risk management and software process standards
• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Manages laboratory equipment
• Supports ISO 17025 compliance and CB Scheme operations as assistant quality manager

EDUCATION

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

PRIOR TO MECA

Vention Medical: Quality Intern; Design & Development Intern
Plexus Engineering Solutions: Product Engineer; Continuous Improvement Specialist

ABOUT

With a passion for out-of-the-box thinking and ensuring quality outcomes, Melina brings experience in product development to further support customer outcomes as a Senior Biomedical Engineer at MECA. She spent time servicing hospital equipment in Tanzania during a summer abroad and continues to support non-profits who assist BMET’s and hospitals in developing countries. Outside of work, she enjoys exploring the outdoors, experimenting in the kitchen, and traveling to new places.

• Technical expert for the IEC 60601-1-2 medical EMC standard and associated CISPR and IEC 61000-4-x series of EMC standards

EDUCATION

University of Wisconsin – Milwaukee: BS in Electrical Engineering

PUBLISHED

Radiated emission measurements to 40GHz: performing accurate and efficient radiated emission measurements in the 1 to 40GHz frequency range: 2004 International Symposium on Electromagnetic Compatibility

PRIOR TO MECA

UL LLC (Underwriters Laboratories Inc.) North America Operations Manager for Medical Device Safety Services

• Led North American Health Science safety service program with focus on process, constraint/barrier identification, process improvement, change management and execution
• Led NA engineering operations teams within a Lean Sigma organization.  Developed operating plans, partnered with lab, engineering management and other UL businesses to achieve corporate objectives and ensure customer satisfaction
• Planned and coordinated projects to improve the operational efficiency and effectiveness following structured DMAIC approach (define, measure, analyze, improve and control)
• Co-developed medical EMC process to allow effective quoting and evaluations across multiple divisions
• Performed medical EMC reviews and trained staff

Underwriters Laboratories Inc., Northbrook Illinois EMC Operations Manager and Senior EMC/Wireless Engineer

• Detailed and specific knowledge of EMC and wireless test equipment, methodologies, and international regulations
• Supervision of multi-shift and weekend EMC lab operation, effectively manage diverse team of technical and non-technical staff
• Developed and implemented operational objectives, goals, and budgets
• Created highest customer service rating of any group at UL Northbrook by constantly focusing staff and client needs
• Responsible for budgeting, research, and procurement of EMC capital equipment
• FCC TCB (Telecommunication Certification Body) Reviewer for wireless products
• Co-designed and developed automated test and measurement systems including 18GHz RF immunity and 40GHz emission measurement systems
• Responsible for staff training and development. Trained UL sales staff, customers, and external groups
• Established and maintained all external accreditations as well as internal quality system. Department’s Laboratory Operations (Quality Assurance) Manager
• Coordinated manufacturers’ product testing to European EMC Directive, Medical Device Directive, FCC, and FDA EMC Requirements
• Provided consultation, cost quotations, pre-test evaluation, test set-up, test performance, and post-test documentation.
• Provided technical design support, including troubleshooting/mitigation, to clients regarding product modifications required for compliance

ABOUT

Upon retirement from UL in December of 2021, Jack was eager to return to the “world of EMC”. He is excited to bring his technical knowledge and experience to MECA to help expand their best-in-class safety service to include EMC. He saw the challenges medical device manufacturers experience working with “traditional” EMC labs who know EMC testing but are not experienced with risk management, essential performance, particular standards nor the basic concepts in the IEC 60601-1-2 medical EMC collateral standard. The MECA team is pulling EMC and “safety” together into one integrated/seamless service that can help ensure compliance, mitigate customers risk, and provide the best-in-class service customers deserve.

Jack’s passion is “building things”, from vacation homes to classic cars to businesses. His proudest “co-build” to date is his family, with his wife Jeanne, three daughters, sons (in-law) and “newest addition” grandson. In his spare time, he enjoys spending time with family, projects around the house, visiting the cabin on the Kickapoo River, running, and working in the garage.

• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Evaluation of risk management standard

EDUCATION

Milwaukee School of Engineering (MSOE): BS in Biomedical Engineering, Minor in Business Administration
Milwaukee School of Engineering (MSOE): MBA

ABOUT

An avid problem-solver with an unwavering desire to learn, it was no doubt that David encompassed a passion for science and engineering at a young age. This excitement led him to his college career at the Milwaukee School of Engineering, where he pursued a Biomedical Engineering degree. For David, the field presented unique challenges, balancing the complexity of medicine with the structure of engineering. Throughout his studies, he was also a member of the MSOE Men’s Ice Hockey team, serving as a captain in his final two years.

After graduating from MSOE in May of 2021, David began working at MECA as an intern, taking a deeper dive into medical device compliance and soaking up as much knowledge as possible. He is now a full-time engineer with MECA and is looking forward to making valuable contributions to the company. When not in the office, David can be found out on the golf course, catching up with friends, or playing hockey at a local rink.

• Evaluation and testing of medical equipment to IEC 60601-1 series of standards
• Evaluation of risk management and software process standards

EDUCATION

University of Wisconsin – Madison: BS in Biomedical Engineering

ABOUT

From a young age, Noah has had a passion for learning how and why things work. Combining this with a detail-orientated and organized mind, he has absorbed as much information as possible from both his education at the University of Wisconsin Madison and his two years as an intern at MECA. As a full-time engineer at MECA, Noah continues to learn and utilizes his knowledge to assist clients through the compliance evaluation process, building relationships along the way. Outside of work, Noah is likely skiing, golfing, up north on the lake, experimenting in the kitchen, reading, or searching for the best movies of all time.

• Technical expert for alarm systems and the IEC 60601-8 standard
• Evaluation and testing of medical equipment to IEC 60601-1series of standards

EDUCATION

DeVry University: Magna Cum Laude BS in Electrical Engineering Technology

STANDARDS COMMITTEES

• AAMI Medical Device Alarms Committee
• US Expert for IEC SC 62A JWG 2 (Medical Alarm Systems)

PRIOR TO MECA

Baxter: Laboratory Technician
Underwriters Laboratories, Inc.: Project Handler

ABOUT

Robert began his career studying Music in college, then Recording at The Recording Workshop.  He worked his way through several studios in Chicago working on acoustic, electronic, industrial and commercial projects. After going back to school for Electronic Engineering Technology, he worked for Underwriter’s Laboratories as a Project Handler in the Hazardous Locations Department.  Other work included Sporting News Radio Engineering, Baxter working on the Colleague IV Pumps and Sanmina as a Diagnostic PCB Repair Engineer. Robert has combined these interests (Music, Electronics, Recording, Engineering, Medical Equipment and Safety Certification) to work at MECA testing 60601 equipment with a focus on Alarm Systems per 60601-1-8.  Robert’s background gives him a unique perspective not commonly found elsewhere in the industry.

• Testing of medical and laboratory equipment
• Development of test fixtures and processes
• Equipment Maintenance

EDUCATION

ITT Technical Institute: AS in Computer Electronics Engineering Technology
Military A School: Electrician Certification
Military C School: Motor’s & Generators Certification
Solectron Global: CDMA Certification

PRIOR TO MECA

Unico: Oil & Gas Field Service Engineer
Carlisle Interconnect Technology: Test Technician

ABOUT

• Data entry
• Answer phones and receptionist responsibilities
• Communicates with clients on project status, notify when engineer’s expertise is required and schedule calls if needed
• Works with engineers weekly on project process, keeping a tracking system of current tasks

PRIOR TO MECA

Brookdale Senior Living: Capital Budget Assistant

ABOUT

With a strong foundation in customer service, Tracy prides herself on hard work, positivity, and building exceptional client relationships. She thrives on working closely with people and brings an optimistic, solutions‑focused attitude to every day, making her a reliable and uplifting presence for both clients and colleagues. Tracy’s natural ability to connect with others—and her dedication to creating meaningful, supportive experiences—makes her a valued member of the MECA team. Outside of work, Tracy cherishes spending quality time with her family, especially her two grandsons, who keep her smiling and inspired. She also enjoys relaxing on tropical vacations whenever she gets the chance, soaking up the sun and recharging. At home, she’s kept company by her dog, Remy, who is never far from her side.