Product & Device Testing
As an A2LA ISO/IEC 17025:2017 accredited mechanical testing laboratory, the RIH Orthopaedic Foundation Test Facility is equipped to utilize scientifically-rigorous methodologies and provide clients with accurate and repeatable data.
Having assisted more than 100 companies with FDA submissions for over 500 medical devices, our team has the knowledge and expertise to assist at every stage of the product development lifecycle. From the market studies to early-stage proof of concept and feasibility analyses to the development of detailed test protocols and submission ready test reports, our team can help.
We assist companies with complete planning of their test programs so that all FDA, EU Medical Device Directive, and other regulatory requirements will be addressed. Our active membership in standards organizations such as ASTM International gives us timely insight into the regulatory environment.
We also help venture capital firms and medical device companies perform technical file due diligence in evaluating their potential investments and acquisitions. We can provide the laboratory space for an in vitro clinical or engineering evaluation, review the technical file for the potential product, or review a company’s entire test program.
Lab Equipment

DXA, Computed tomography and micro CT capability
Portable C-arm
3D Volumetric Bone Mineral Density Software
Multiple Uniaxial, biaxial servo/hydraulic, EM Torsion and Electropuls load frames with digital data acquisition and various capacity load and torque cells
Unconstrained 6 degrees of freedom kuka robot testing system set-up with 6 axis load cell
Faxitron – high resolution X-ray imager
Optotrak Certus 3-D motion tracking system
Qualisys 3-D motion tracking system
Custom-designed fixtures for testing biologic material
Conference room with A/V equipment
Digital camcorder with remote wireless microphone
Previous Testing Work
RIH Orthopaedic Foundation has expertise and legal certification to test certain sports equipment, as well as a large array of medical products and equipment. Examples of our previous testing includes:
Joint Replacement Implants
Partial and total hip
Total and unicompartmental knee
Shoulder
Elbow
Phalange
Ankle
Wrist
Extremities Devices
Bone plates
Bone screws
Bone staples
Intermedullary fixation devices
Surgical Instruments
Surgeon evaluation and performance studies
Reliability Demonstration Studies
Spinal Devices
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
Wear and Simulation
High cycle fatigue testing
Ultra-high molecular weight polyethylene wear
Fretting corrosion
Autoclave aging
Mass loss evaluation
Metallographic surface evaluations
Pressure mapping
Range of motion
Sports Equipment
Women’s lacrosse sticks
Bicycle helmets
Skateboarding and roller-skating helmets
Recreational snow sports helmets
Accreditations
The backbone of our laboratory is our Quality Assurance Program. It is through this commitment to quality that we have achieved accreditation from the American Association for Laboratory Accreditation (A2LA). As such, our QA program meets the requirements of ISO/IEC 17025, “General Requirements for the Competence of Testing and Calibration Laboratories.” While we perform many more tests beyond the scope of this A2LA accreditation, you should always be confident in our ability to utilize a scientifically-rigorous methodology to provide you with accurate and repeatable data. For additional insight into our QA program, please contact us to request a copy of our QA Manual. View our A2LA certificate by clicking here.
Our current scope includes the following tests:
FIL (Rule 25) – The Crosse
US Lacrosse (Rule 9) – Manufacturer’s Specifications
CPSC 16 CFR 1203 – Safety Standard for Bicycle Helmets, Final Rule
ASTM F1446 – Standard Test Method for Equipment and Procedures Used in Evaluating the Performance Characteristics of Protective Headgear
ASTM F1492 – Standard Specifications for Helmets Used in Skateboarding and Trick Roller Skating
ASTM F2040 – Standard Specification for Helmets Used in Recreational Snow Sports
ASTM F1717 – Standard Test Method for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F1798 – Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F543 – Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F382 – Standard Specification and Test Method for Metallic Bone Plates
ASTM F564 – Standard Specification and Test Method for Metallic Bone Staples
ASTM F2009 – Standard Test Method for Determining the Axial Disassembly Force of Taper Connections of Modular Prostheses
ASTM F2028 – Standard Test Method for Dynamic Evaluation of Glenoid Loosening or Dislocation
ASTM F 2193 – Standard Specification and Test Methods for Components used in the Surgical Fixation of the Spinal Skeletal System