Mechanical Testing Services

FOR MEDICAL DEVICES

TRUSTED MECHANICAL TESTING COMPANY FOR OVER 20 YEARS

Empirical Technologies, founded by Dawn Lissy is a small business with 24-hour operations and an expert team of advanced engineers to help you execute your test plan. We offer a complete mechanical testing 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 testing services and our philosophy of continuous improvement in all that we do, enables us to offer the best in the mechanical testing services industry. The types of components that we test are limitless and our medical device testing scope is one of the largest under ISO/IEC 17025 : 2017.

LIST OF MECHANICAL TESTING PERFORMED AT EMPIRICAL

  • TENSILE TESTING

    A tensile test is one of the mechanical testing services where we apply force to separate the material or assembly. Most often used for cervical spinal constructs, it is an uncommon test for medical devices.

  • WEAR & SIMULATION TESTING

    Wear, or simulation, testing is used to evaluate the performance of a device under real world conditions. This testing is used for all motion preserving joint constructions to determine if they are capable of performing their function and how much wear they experience. This allows us to determine the usable life of the implant under clinical conditions.

  • TORSION TESTING

    Torsion testing is the application of force at a distance from a fixed center (moment). We commonly use torsion to load joins that are in motion such as hips, knees, and artificial discs.

  • FATIGUE MECHANICAL TESTING

    Fatigue is the cyclic loading of a specimen. We use fatigue to estimate the life of a specimen to make sure it meets its design criteria. This is one of the most common testing services for medical devices and materials in general.

  • NON-STANDARD TESTING

    We work with dozens of customers every year that are pushing the envelope and need help navigating regulatory approval and providing the data to support submissions on these cutting-edge devices.

  • AXIAL COMPRESSION

    Axial compression testing is a mechanical testing service where we apply a force to compress the specimen. This is the gold standard in medical device testing and represents most of the fatigue and static testing that we perform at Empirical.

  • SHEAR TESTING

    Mechanical testing companies offer Shear testing wherein two forces are applied moving in opposite, but parallel, directions are applied to the part of the assembly. Commonly used on lumbar spine products to simulate L4-S1 loading.

  • INSTRUMENT & LIFE CYCLE

    We perform instrument life cycle testing to help our customer improve their designs and functions and get the most out of their products. Empirical Technologies is a mechanical testing company that designs custom mechanical tests as a service for instruments based on their clinical usage that replicates the OR.

  • LOT VERIFICATION TESTING

    In lot verification, one of the tests in the list of mechanical testing, we are confirming that each lot of product meetings the minimum criteria for release. This is a manufacturing verification test.

DEDICATED SCREW TESTING

  • DRIVING TORQUE

    This is a test of how much force the screw takes to drive into a known substrate. We have custom test beds to perform this testing and customers use the data to optimize design as well as make sure they are not overloading the bone.

  • PULL OUT

    Pull out is the resistance of the screw to being pulled (or sometimes levered) out of its substrate. This mechanical testing service is often performed by mechanical testing companies at the end of a driving torque test and helps customers understand just how much hold their screw has in a bone substrate.

  • SHEAR, FATIGUE, AND LEVER

    These tests are performed to tell how much force a screw can take when the plate or rod it is holding on to is moving or levering the screw. A critical component to knowing how strong the fixation is when you take the substrate out of the picture.

For a vast list of test standards that Empirical is accredited or certified to conduct,

please visit our Quality Standards page. In addition, we offer custom testing services.
Quality Standards

CUSTOM TESTING

  • extensive expertise

    Empirical has extensive expertise to design tests to meet any customer need. Partnering with our customers to navigate the testing process is our specialty. Whether it is novel material, or a cutting-edge implant design, we have worked on hundreds of projects, conducting everything in the list of mechanical testing from inception to realization and always keep the goal of approval and reality of costs front and center. If a standard doesn’t exist for a project our team has the expertise to create a protocol that can be used to test your device. We understand what will be acceptable to the the regulatory agencies around the world to get your device cleared as quickly as possible.

  • leader in evaluating devices

    With over 75 years of combined medical device, regulatory and testing experience, we lead the way in evaluating devices and helping our customers get regulatory approval in whatever jurisdiction that they operate in. We have worked on thousands of projects and performed testing services requiring simple 501ks to PMA/IDEs. We integrate our mechanical testing services team into yours. This allows us to seamlessly transfer information to us and we can monitor and update the progress towards the goal and reflect it back to you for internal team updates. Our goal is to function as a part of your team and share in the success of your goals.

  • meet customers goals

    As a mechanical testing company, our goal at Empirical is to help our customers meet their goals of safety and efficacy. That is why we are not just experts at mechanical testing services, but maintain regulatory, manufacturing and industry expertise that allows us to help customers achieve success despite a changing regulatory environment.

    At Empirical, we sit down with our customers to review every project and work to meet the unique challenges that their devices bring to us.     We use our expertise as a mechanical testing company to lower your costs and time to market by designing test plans that efficiently meet the goals of your team. We help our customers get their products to market in multiple regulatory jurisdictions all over the world. Our mechanical testing services and regulatory expertise allows us to choose the best path forward and saves time as well as money.

What sets Empirical apart?

  • Trusted Reputation

  • Floating Effect

  • Comprehensive & proven solutions

  • 20 + years of experience

  • Regulatory-ready test reports

  • Custom mechanical testing and protocols

  • Additive manufactured and component testing

  • Titanium subject matter experts

  • ISO/IEC 17025 Accredited Lab