Dental Implants | Extremities Devices | Joint Replacement Implant | Spinal Devices | General Device Testing |
Surgical Instruments | Non-Standard/Custom Testing | Wear and Simulation
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 Corp.’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 Corp. 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.
Watch the Medical Device Testing Services Overview Video
Who is Empirical Testing Corp? What are our capabilities? What are our specialties? Why choose Empirical? How do we contact Empirical to get started?
Dennis Buchanan, Engineering Manager at Empirical Testing Corp, answers these common questions clients have about our medical device testing lab?
Keep reading to learn more about our various medical device testing services:
Dental implants are an exciting and up-and-coming sector in medical devices, and Empirical is accredited to the only existing test standard, ISO 14801:2007. As technology for these implants advances, Empirical has cemented itself as a leader in the field by staying at the cutting edge of this test methodology. Having tested dental implants of multiple materials and geometries, Empirical has extensive experience with specimen potting and fixturing.
- Dental implant systems
- Dental screws
- Dental posts
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.
As the complexity of extremities devices continues to progress, more and more implants require mechanical testing for FDA clearance. Whether static testing of a bone screw or dynamic testing of an intermedullary fixation device, Empirical can help bring your next extremities device to market with best-in-class testing. With standard, in-house fixturing for required testing of bone screws, plates and rod systems, save time and money by partnering with Empirical.
- Bone plates
- Bone screws
- Screw/rod interconnection properties
- Cranial devices
- Maxial facial devices
- Intermedullary fixation devices
- Bone staples
- External fixation devices
- ASTM Standards
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.
Empirical is an industry leader in both small-joint and large-joint testing. With resources to perform both characterization and wear testing of multiple joint types, as well as specimen assembly/potting and clean/dry/weigh (CDW) per ASTM F1714, we can help manage all testing necessary for whatever your regulatory path to market may be.
- Shoulder replacements
- Elbow reconstruction and replacement devices
- Partial and total hip joint prosthesis
- Total and Unicompartmental Knee Replacement
- Small joint implants
- Phalange replacement devices
- Add Standards and the link
Empirical has been at the forefront of spinal device testing for over two decades. For fusion, stabilization or motion preserving, Empirical is your best choice for traditional or innovative spinal implant testing.
Technology behind spinal devices has evolved significantly in the past decade, and Empirical has been on the cutting edge of spinal device testing every step of the way. Whether your device is an adjunct to fusion or it employs motion-preserving technology, let our expertise in spinal devices guide you through a successful test plan.
- Pedicle screw systems
- Facet fixation systems
- Interbody Fusion Device (IBFD)
- Vertebral Body Replacement (VBR)
- Artificial disc
- Nucleus Pulposus (N-P) replacement
- Facet replacement
- Posterior dynamic stabilization systems
- Anterior cervical plates
- Anterior lumbar plates
- Interspinous devices
- Occipital-Cervical-Thoracic Systems
- Standalone devices
- New materials and manufacturing processes
- Complicated geometries
- Add Standards and links
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.
Empirical’s guidance and testing will ensure your instruments meet or exceed the latest regulations.
Without proper surgical instrumentation, orthopedic devices would be rendered highly ineffective. Empirical understands that quality instruments are essential to the complete package of any medical device. That’s why we also offer life cycle testing for surgical instruments. We’re experts in a number of static and dynamic test modes based on custom protocols derived directly from surgical technique guidelines. From drop- and impact-testing of insertion tools to fatigue testing of surgical tools, Empirical can help you with your instrument testing regardless of your device or its indication. If there’s no existing ASTM standard, we’ll develop custom protocols to meet the appropriate regulatory requirements.
- Insertion tools
- Surgical instruments
- Strain-gauge testing
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 18192-1and 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
Here is a sampling of our medical device testing capabilities:
- Protocol development & Review
- Custom test method development & validation
- Cantilever bending
- Bi-axial torsion & compression
- Multi-axis loading
- Product or component validation/verification
- Product lot verification
- Component strain gaging
- Process effect on durability
- Process effect on material properties
- Accelerated aging (Shelf-life)
- Environmental aging/degradation
- Corrosion effect on durability
- Environmental testing (temp, humidity, salt concentration)