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