Brian Biersach

Brian Biersach

President, Sr. Biomedical Engineer

Founder of Medical Equipment Compliance Associates, LLC in 2002

  • Technical expert for the medical IEC 60601-1 series of standards
  • Technical expert for the 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 the 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 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.

Jeremi Peck

Jeremi Peck

Vice President, Sr. Biomedical Engineer
  • 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 the 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 the medical standards

EDUCATION

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

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 MECA’s VP since 2004, Jeremi has facilitated its growth into one of the top medical device testing labs in the industry. His approach to compliance engineering and safety testing has solidified his reputation as a smart, approachable leader with a deep knowledge of standards and a willingness to both educate and learn. As a husband and father to two boys, he understands that diplomacy and discussion not only helps in his life outside the lab, it provides him with the expertise to engage and partner with clients as he guides them through the compliance process. When away from the office, if he isn’t at a sporting event rooting on his kids, you’ll find him with his family in their RV, out on the boat fishing, or cheering for the Milwaukee Brewers.

Alex Grob

Alex Grob

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

EDUCATION

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

STANDARDS COMMITTEES

– US Expert for IEC SC 62A MT 28 Convener (IEC 60601-1 Electrical hazards)
– CO-CHAIR of AAMI ES (Electrical Safety) Committee, (responsible for AAMI ES 60601-1)

PRIOR TO MECA

GE Healthcare: Director, Regulatory Affairs – Standards

  • 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, 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 20 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 & Assistant Quality manager at MECA.  Alex is involved in the standards development process as the Convener of IEC SC62A MT28 for electrical hazards as well as the Co-chair of AAMI-ES, these committees are responsible for IEC 60601-1 and the US adoption ANSI/AAMI ES 60601-1.

Justin Marasco-Martineau

Justin Marasco-Martineau

Sr. Biomedical Engineer
  • 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 the 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 the medical standards
  • Laboratory coordinator and equipment manager

EDUCATION

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

ABOUT

When Justin joined MECA in 2013, not long after graduating from MSOE, he quickly established himself as someone who is dedicated to helping our clients maneuver through the compliance process by partnering with them to better understand how the standards apply to their devices. He is passionate about being a team player and empowering his colleagues in their growth by setting an example of great customer service and building lasting relationships. Justin is a strong believer in work-life balance and enjoys spending time outside of work camping and organizing game nights with friends and family. He is the proud dog father of two beautiful Siberian Huskies, Bandit and Riley, who have become mascots in the MECA office.

Aly Loepfe

Aly Loepfe

Biomedical Engineer
  • Evaluation and testing of medical equipment to IEC 60601-1 series of standards
  • Evaluation of risk management standard
  • Training and seminars on the medical standards
  • Business planning

EDUCATION

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

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.

Robert Koch

Robert Koch

Compliance Engineer
  • 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.

Cathi Koch

Cathi Koch

Account Executive, Quality Manager
  • Quality Manager for IEC/ISO 17025 laboratory quality system
  • Auditor, IEC/ISO 17025 laboratory quality systems
  • Client relations
  • CRM Administrator
  • Quoting coordinator
  • Project scheduling
  • Purchasing manager

ABOUT

As MECA’s Account Executive and Quality Manager, Cathi does more than manage client relationships and oversee compliance of our quality system. With more than 20 years of business administration experience, in industries from entertainment and law to health care and government, she’s become passionate about developing innovative solutions to wrestle through bureaucracy and deliver for her clients both internal and external. She believes that collaboration, embracing diversity, and being a little unconventional are the back bones to her success. When she’s not at work, you’ll likely find her wandering markets looking for interesting ingredients, checking out live music, or in her car singing power ballads.

Larshay Lee (Lee)

Larshay Lee (Lee)

Engineering Technician
  • 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

Lee first got his feet wet in electrical technology as an Electricians Mate in the US Navy. During his service, he learned how to solve problems while under extreme pressure and that being a person of strength and integrity can take you further than you’d expect. When he got out of the Navy, he took the skills he learned about electrical technology, coupled them with his desire to take action, achieved his AS in EET and set off on a career that requires him to think on his feet, troubleshoot problems, and keep things rolling in the lab. Lee has become an integral part of the MECA team and the levity he brings to the lab makes the intensity of the work we do more light-hearted. As a dad of four, most of his time outside of work involves making sure his kids get where they need to be but also finds time to enjoy hanging with friends and family and watching the Milwaukee Bucks.

Tracy Klier

Tracy Klier

Administrative Assistant
  • 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

Fairly new to MECA but no stranger to customer service, Tracy prides herself in hard work and excellent client relations. Before MECA, Tracy worked in the corporate healthcare industry doing Office Services and Buildings Accounting. Tracy enjoys working closely with people and looks for positivity every day. She loves to spend quality time with her children and likes to relax on tropical vacations.

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