rhode island orthopaedic foundation, rihof, orthopedic testing, medical consulting, failure analysis, regulatory analysis, 3rd party devise analysis, fda approval

P: (401) 444-4414
F: (401)-444-4418
Coro West, Suite 404
1 Hoppin Street
Providence, RI 02903

 
 
 
 

About Us

rhode island hospital research, test facility orthopedics, test facility orthopaedics, device failure analysis, research development orthopedics, regulatory processes orthopedics, bioengineering laboratory, brown medical school, private industry, spine surgery training, spine surgeon training laboratory, orthopedic products testing, sports protective equipment, coordinate bioskills, coordinate sales labs, quality assurance lab orthopedics, quality assurance program, medical consulting,failure analysis, regulatory analysis

For medical device companies in need of engineering assistance with regard to device failure analysis, research and development or regulatory processes, the RIH Orthopaedic Foundation Test Facility provides unique solutions to problems encountered in the field of Orthopaedics.

The RIH Orthopaedic Foundation Test Facility works in close conjunction with the Bioengineering Laboratory at Brown Medical School. Created in 1998, this facility provides a resource for the Department of Orthopaedics and for private industry. Our primary services include the testing of orthopaedic products, sports protective equipment for commercial clients and the coordination of bioskills / sales labs.

Our QA Program

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. Find our A2LA certificate here by searching RIH Orthpaedic Foundation.

Management and Technical Staff

Edward Akelman, M.D. – President
Joseph J. Crisco III, Ph.D. – Director of Bioengineering at the Warren Alpert Medical School
Sarath C Koruprolu, M.S. – Test Engineer
Ryan Rich – Test Technician
David J. Paller, M.S. – Project Consultant RIH Orthopaedic Foundation

Clinical Staff

Do you want a clinician to try out your product in our cadaver lab? Whether you are seeking surgeon feedback, voice of the customer (VOC), or just want to perform simulated use testing, we offer access to clinical staff. These clinicians have operative privileges at Rhode Island Hospital or other local hospitals. All orthopedic clinicians are either board-eligible or board-certified. Specific areas of expertise include:

Christopher Born, M.D. – Trauma
Craig P. Eberson, M.D. – Pediatrics
Paul Fadale, M.D. – Sports medicine
Andrew Green, M.D. – Shoulder and elbow
Michael J. Hulstyn, M.D. – Sports medicine
Mark Palumbo, M.D. – Spine
Jonathan Schiller, M.D. – Pediatrics and hip arthroscopy
Arnold-Peter C. Weiss, M.D. – Hand

Equipment
  • Multiple Uniaxial and biaxial servo/hydraulic load frames with digital data aquisition and various capacity load and torque cells
  • Unconstrained spine test set-up with 6 axis load cell
  • Custom-designed fixtures for testing biologic material
  • Two OEC Fluoroscopic C-arms with digital picture/video capture
  • Faxitron - high resolution X-ray imager
  • Computed tomography and microCT capability
  • DEXA bone density analysis
  • OptoTrak 3-D motion tracking system
  • Qualisys 3-D motion tracking system
  • Four complete arthroscopic stations
  • Tissue removal, ablation, and cautery systems
  • Pneumatic and battery powered hand tools
  • Surgical instrumentation
  • Steam/EtO sterilization
  • Portable X-ray
  • Three Necropsy Tables
  • Conference room with A/V equipment
  • Digital camcorder with remote wireless microphone

 
 
 

Medical Consulting

 

Failure & Regulatory Analysis

 

3rd Party Device Analysis

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The bioskills suite located within our lab can accommodate large surgeon education and sales training labs with two fluoroscopes, two necropsy tables, and four complete arthroscopic stations.

 

We have assisted more than 100 companies with their FDA submittals on over 500 medical devices and have worked with R&D departments designing specialized, non-standard test designs.

 

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.

 
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learn more about 3rd party device analysis, orthopedic product testing, orthopaedic product testing, test program planning, regulatory requirements
 
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