MECHANICAL TESTING SERVICES FOR MEDICAL DEVICES
Trusted Mechanical Testing for Over 20 Years
Empirical 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 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 disciplines and our philosophy of continuous improvement in all that we do, enables us to be the best in the mechanical testing services industry. The types of components that we test is limitless and our medical device testing scope is one of the largest under ISO/IEC 17025 : 2017.
What sets Empirical apart?
- Trusted Reputation
- Comprehensive & proven solutions
- Extension of your team, providing expert guidance & timely execution
- 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
COMMON MECHANICAL TESTING PERFORMED AT EMPIRICAL:
A tensile test is when we apply force to separate the material or assembly. Most often used for cervical spinal constructs, it is an uncommon test for medical devices.
Shear testing is applying two forces moving in opposite, but parallel, directions are applied to the part of assembly. Commonly used on lumbar spine products to simulate L4-S1 loading.
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 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 tests for medical devices and materials in general.
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 usable life of the implant under clinical conditions.
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. We design custom tests for instruments based on their clinical usage that replicates the OR.
Lot Verification Testing
In lot verification we are confirming that each lot of product meetings the minimum criteria for release. This is a manufacturing verification test.
This is everything under the sun. From novel materials to cutting edge designs that have no accepted standard. 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 testing is applying 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.
Dedicated Screw Testing
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 is the resistance of the screw to being pulled (or sometimes levered) out of its substrate. This is often performed 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.
Please visit our Quality Standards page for a vast list of test standards that Empirical is accredited or certified to conduct. In addition, we offer custom testing services.
Empirical has deep expertise in designing tests to meet any customer need and partnering with our customers to navigate the testing process. Whether it is novel material, or a cutting-edge implant design. We have worked on hundreds of projects from inception to realization and always keep the goal of approval and reality of costs front and center. We have worked on dozens of projects every year that have no standard that you can use to guide testing and have the experience to understand what will be acceptable for the regulatory agencies around the world so that you are not just testing, you are actively working to get your device cleared in the shortest time possible.
Our goal at Empirical is to help our customers meet their goals of safety and efficacy in all the things that we do. That is why we are not just mechanical testing experts, 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.
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 hat they operate in. We have worked on thousands of projects requiring simple 501ks to PMA/IDEs. We integrate our team into yours so that you can 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.
We use our expertise 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 and regulatory expertise allows us to choose the best path forward and saves time as well as money.