What sets Empirical Testing Corp. apart?
- Trusted Reputation
- Comprehensive & proven solutions
- Extension of your team, providing expert guidance & timely execution
- 20 + years of experience
- Regulatory-ready test reports
- Custom protocols and testing
- Additive manufactured and component testing
- Titanium subject matter experts
Empirical Testing Corp. is a woman owned, small business with 24-hour operations and an expert team of advanced engineers to help you execute your test plan. We offer a complete service package, including an unsurpassed technical report and a comprehensive partnership to guide you to successful project completion faster than our competitors. Empirical’s objective is to furnish you with accurate and reliable test reports that can be submitted to meet global regulatory requirements, including FDA and CE marketing approval. Our proven expertise in many mechanical engineering disciplines and our philosophy of continuous improvement in all that we do enables us to be the best.
Empirical Testing Corp. specializes in Medical Device Testing and Aerospace & Defense Testing
General Device Testing
Medical device development from many fields of medicine incorporates mechanical testing. Trust Empirical’s experience with projects of any type. We also test:
- Robotics components
- IQ/OQ testing
- Lot verification testing
- Consumer goods
- Anything requiring mechanical evaluation
With a commitment to the entire medical device industry, Empirical also performs mechanical testing on non-orthopedic medical devices. Rely on our experience with determining appropriate test methods and standards, selecting test parameters if necessary, and designing and manufacturing custom test blocks and fixtures.
If you have a device for a novel application or one to improve existing technology, let us know how we can provide a simple and straightforward approach to mechanical testing.
We create custom protocols as well as research for relevant acceptance criteria.
Innovation often precedes standards. When new methods are needed, Empirical ensures optimal test plans and methods for obtaining regulatory approval.
Modern-day medical devices that push the envelope with cutting-edge technology and innovative design must still undergo rigorous mechanical testing prior to regulatory clearance. However, some devices might not fit the indication level or overall intent of a prescribed test standard.
Empirical will lay out a sound mechanical test plan, and develop custom test methods to answer specific questions on device design and characterization, interconnection strength, and overall safety and efficacy of your device. If your device is brand new to the market, or you’re adding a new component to an existing family of products, Empirical’s biomedical engineers will meet your custom testing needs efficiently with world-class quality.
Wear and Simulation
Accredited to internationally recognized standards for wear testing — ISO 18192-1 and ASTM F2423 — Empirical’s in-house, six-station wear testers are complemented by access to a 12-station hip simulator and a four-station knee simulator — all with loaded soak controls.
Motion-preserving spinal implants such as artificial spinal discs, facet replacement devices and posterior dynamic stabilization systems are constantly pushing the envelope with cutting-edge technology and design. Because these devices feature moving parts with articulating surfaces, wear testing is required to determine the amount of particulate generated throughout the functional life of the implant.
Empirical is accredited to internationally recognized standards for wear testing – ISO 18192-1 and ASTM F2423 – and has two six-station wear testers that can handle implants of all four types of non-fusion technologies. With access to a 12-station hip simulator and three four-station knee simulators — all with loaded soak controls — Empirical also can manage simulation testing for hip and knee implants.
Empirical also offers small joint testing, including shoulder, wrist and digital implants. We also test:
- Artificial discs posterior dynamic stabilization systems
- Facet replacement devices
- Nucleus Pulposus (N-P) replacement devices
- Hip implants
- Knee implants
- Shoulder implants
- Wrist implants
- Digital implants (phalangeal)
- Ankle implants