IEC 60601-1 - Key Persons
Job Titles:
- Biomedical Engineer
- Chief Biomedical Engineer, Quality Manager / 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 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
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.
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.
Job Titles:
- 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 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
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.
Job Titles:
- 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 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
Job Titles:
- Biomedical Engineer
- Biomedical Engineer, Eng. Lab Manager / Technical Expert for the Medical IEC 60601 - 1 Series of Standards / Technical Expert for the Laboratory Equipment IEC 61010 - 1 Series of Standards
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 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 Melina can be found exploring the outdoors, visiting craft breweries, and experimenting with new recipes in the kitchen.
Job Titles:
- Compliance Engineer / Technical Expert for Alarm Systems and the IEC 60601 - 8 Standard
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.
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.