Empirical is made up of mechanical testing experts, regulatory consultants, engineers, highly-skilled machinists, lab technicians and project managers.
Dawn Lissy, Founder & President
Dawn Lissy is a biomedical engineer, entrepreneur, and innovator. Since 1998, the Empirical family of companies (Empirical Testing Corp., Empirical Consulting, LLC, and Empirical Machine, LLC) has operated under Lissy’s direction. Empirical offers the full range of regulatory and quality systems consulting, testing, small batch and prototype manufacturing, and validations services to bring a medical device to market. Empirical is very active within ASTM and has one of the widest scopes of test methods of any accredited independent lab in the United States. Because Lissy was a member of the FDA’s Entrepreneur-in-Residence program, she has first-hand, in-depth knowledge of the regulatory landscape. Lissy holds an inventor patent for the Stackable Cage System for corpectomy and vertebrectomy. Her M.S. in biomedical engineering is from The University of Akron, Ohio.
Chris Lissy, CEO
Chris has worked with Dawn to build Empirical from a single employee in 1998 to the full team of three companies (Empirical Testing Corp., Empirical Consulting, LLC and Empirical Machine, LLC) 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, Vice President of Empirical Consulting
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.
Dennis Buchanan, Engineering Manager
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 maximize the opportunity to achieve regulatory clearance for your medical device as quickly as possible, with the highest return on your testing investment.