The Experts in U.S. & International Comprehensive Mechanical Testing
When your product or device is ready for testing, it is essential that you have the confidence in a testing partner who will help you realize timely and effectual market success.
At Empirical Testing Corp., we have proven successes throughout the world in our standard and custom protocols for feasibility, product development, release testing, safety batch analysis, and batch/lot quality testing.
Building on our reputation as a global leader in the medical device testing industry, Empirical Testing Corp. brings the same commitment to excellence to other industry segments as well. It’s why the largest and most respected orthopedic companies partner with Empirical to ensure product integrity and repeatable test results.
Our comprehensive suite of in-house mechanical testing solutions will determine if a material or part is suitable for its intended application by measuring properties such as elasticity, tensile strength, elongation, fracture toughness, impact resistance, stress rupture and the fatigue limit.
In our mechanical testing lab, you will find world renowned experts with over 60 years of combined technical experience on our team.
We specialize in developing custom protocols and test methods for any type of mechanism our customers create, including validation methods after development. If the device requires mechanical evaluation, whether an ASTM/ISO standard exists, or a custom protocol and test method need developed, we ARE the global experts in mechanical testing.
Partner with Empirical to Achieve Regulatory Clearance or Approval – The First Time
You have a brilliant idea that could revolutionize patient care. We have the tools, resources and expertise to help you bring that idea to fruition.
The Empirical family of companies is your one-stop shop partner in bringing your medical device to the global market. With three companies under one roof, we offer the full range of consulting, testing, manufacturing and validation services for class I, II and III devices. We collaborate with you to bring your product to market. Trust Empirical to guide you through the often complex and ever-evolving process of gaining and maintaining regulatory clearance/approval you need to improve and save lives.
We pride ourselves on our integrity, innovation and industry experience.
When you partner with Empirical, you’re working with the most respected industry experts. We start with a sound plan to guide you through regulatory issues as well as a relevant, efficient test plan. Because our family of companies offer a full range of services to get your device to market once its design is complete, you are able to customize the partnership plan that will help you best reach your success.
Our team at Empirical Consulting will assess your project, whether you’re U.S.-based, working to enter the U.S. market or focused abroad. Empirical Testing Corp. will carry out whatever tests you need to compile the data required by various regulatory agencies; we have the widest accreditations of any independent lab in the United States. Through Empirical Machine, we offer prototyping and small-batch manufacturing to support the development of your medical device.
We Work to Improve Return on Investment Throughout Development
- Count on Empirical’s invaluable industry insight and medical device testing expertise to craft a solid plan for getting your product to market.
- We’ll recommend testing protocols, requirements and regulatory path options, testing options and requirements, and relevant timelines.
- Empirical knows this industry, so we know what’s already on the market and how your medical device compares to existing technology. We’ll guide you on the best path forward for a competitive edge against existing products.
- Empirical Machine can manufacture prototypes and/or test specimens.
- The experts at Empirical Consulting and Empirical Testing Corp. regularly participate in the design verification phase of production.
- We validate processes to ensure quality is maintained during critical production times.
- Empirical Machine offers prototyping, small-batch manufacturing and gap manufacturing to save you time and provide efficiencies that round out our suite of services.
- Timely, consistent communication throughout the testing phase keeps you informed of all successes and failures. Whether we’re making functional, kinematic or wear assessments; evaluating static and fatigue properties; measuring load-induced subsidence; or determining endurance properties, our commitment to your success means we keep you in the loop.
- You are welcome to visit our Colorado Springs site to see firsthand how your medical device is performing.
- When we complete your medical device testing, Empirical Testing Corp. delivers the most comprehensive test report in the industry. Our team at Empirical Consulting knows how to compile that data and present it to the standards and expectations of various regulatory agencies.
- Our test report is industry-recognized for its accuracy, thoroughness and repeatability. It includes state-of-the-art photographs of your medical device throughout the testing period.
- Empirical test reports meet the requirements of appropriate regulatory agencies to streamline your medical device through the approval process and get it to market.
- We celebrate your success as you bring your medical device to market.
> History Since 1998, Empirical has helped clients get their medical devices to market.
> Staff Empirical is made up of mechanical testing experts, regulatory consultants, engineers, highly-skilled machinists, lab technicians and project managers.
> Empirical Quality Empirical holds the widest range of and highest quality level of accredited test standards or certificates for medical devices currently available in the United States. We are committed to providing the highest standards in service and accreditations for our customers.
President & CEO Dawn Lissy is a biomedical engineer, an entrepreneur and an innovator. For more than 20…
Co-Founder & CEO Chris has worked with his wife, Dawn, to build Empirical from a single employee in…
Vice President of Empirical Consulting Meredith May, a biomedical engineer, brings decades of orthopedic implant industry experience in…
Engineering Manager With more than 25 years of experience in the medical device industry, Dennis has built his…