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As an A2LA ISO/IEC 17025:2005 accredited mechanical testing laboratory solely specializing in medical device testing, Empirical Testing is equipped to respond to a fast-paced product development environment.

While Empirical Testing’s extensive scope of accreditation covers a wide variety of medical devices — from spinal to extremities — Empirical also is dedicated to development and testing of custom protocols for devices that push the envelope of existing technologies.

Empirical Testing has 24-hour operations and a team of biomedical engineers to help you execute your test plan. We offer a complete service package, including an unsurpassed technical report. 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 biomechanical engineering disciplines and our philosophy of continuous improvement in all that we do enables us to be the best. Certification

 


  • Dental Implants

    For posts, abutments and other implants, Empirical Testing is accredited to the only existing test standard, ISO 14801:2007 in this innovative sector of medical devices.
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  • Extremities Devices

    Whether single-cycle static testing of a bone screw or dynamic testing of an intermedullary device, with standard, in-house fixturing for bone screws, plates and rod systems, Empirical is your choice for extremities implant testing.
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  • Joint Replacement Implant

    Performing characterization and wear testing of all joint types, Empirical is an industry leader in both small-joint and large-joint testing.
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  • Spinal Devices

    Empirical has been at the forefront of spinal device testing. For fusion, stabilization or motion preserving, Empirical is your best choice for traditional or innovative spinal implant testing.
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  • General Device Testing

    Medical device development from many fields of medicine incorporates mechanical testing. Trust Empirical’s experience with projects of any type.
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  • Surgical Instruments

    Evaluating function and durability, Empirical’s guidance and testing will ensure your instruments meet or exceed the latest regulations.
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  • Non-Standard/
    Custom Testing

    Innovation commonly precedes standards, and when new methods are needed, Empirical’s experience ensures optimal test plans and methods for obtaining regulatory approval.
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  • Wear and Simulation

    Accredited to internationally recognized standards for wear testing — ISO 18192-1 and ASTM F2423 — Empirical Testing’s in-house six-station wear testers are complemented by access to a 12-station hip simulator and three four-station knee simulators — all with loaded soak controls.
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