Dawn Lissy is a biomedical engineer, an entrepreneur and an innovator. For more than 20 years, she’s worked with clients to bring groundbreaking medical devices to market.
Since 2001, she has participated in ASTM committees focusing on orthopedic devices, including committee F04.25 (for spinal implant devices), F04.21 (for osteosynthesis) and F04.22 (for orthopedic implant devices). Dawn’s drive to develop scientifically based test results and deliver outstanding customer service throughout her clients’ product development cycles is reflected in the work she conducts to educate customers, vendors and regulatory bodies alike.
She was recently selected for the FDA’s Entrepreneurs-in-Residence program, which invited top professionals from the medical device industry to work with the FDA to streamline and improve the approval process for devices. Learn More…
Chris has worked with his wife, Dawn, to build Empirical from a single employee in 1998 to the full team of three companies (Empirical Testing Corp., Empirical Consulting and Empirical Machine) that support the work of medical device innovators the world over.
With a degree in biology from the University of Akron and a proven track record of developing startup companies, Chris guides the Empirical team to bring client devices to market in the shortest possible time and with the greatest possible value.
Meredith May, a biomedical engineer, brings decades of orthopedic implant industry experience in manufacturing, design, regulatory and quality to your project team. She has been successful at bringing orthopedic products to market on shoestring budgets with condensed timelines, so she understands the needs of orthopedic implant companies.
Meredith has a master’s degree in entrepreneurship and brings an even greater business knowledge specific to small- to medium-sized companies. She is a regulatory expert who’s worked on all aspects of bringing a medical device to market, including regulatory affairs, quality assurance, process development, product development, quality systems, risk assessment, validation, verification and CAPA.
With more than 25 years of experience in the medical device industry, Dennis has built his career and reputation not just on his technical expertise, but also on his commitment to his clients. His depth of experience and understanding of the industry is part of the added value of working with Empirical.
Dennis has worked for major international biomedical corporations as well as small, independent testing labs. He’s been on development teams responsible for developing a wide range of medical devices for large and small joint arthroplasty, trauma, spinal products and more. Because he’s personally worked through the product development cycle for the devices he’s invented as well as for corporations, he knows what it takes to get your product to market.
Dennis is committed to solving the tough problems, understanding clients’ needs and enabling them to achieve their goals. He’ll help you develop and execute your plans to ensure that your medical device achieves regulatory clearance as quickly as possible with the maximum return on your testing investment.