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Grand Rapids, MI
Alpharetta, GA
Middletown, RI
Hopkins, MN
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. The backbone of our laboratory is our QA program and our primary services include the testing of orthopaedic products, sports protective equipment for commercial clients and the coordination of bioskills / sales labs.
MEDICAL CONSULTING 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. Various surgical instruments, powered hand tools, tissue management devices, and medical imaging systems are also available. To view our complete list of equipment, click here. Biologic or synthetic models can be provided for any part of the anatomy. Our fully equipped conference room (catering available) is suitable for use in presentations in surgeon education courses and marketing/sales training. Afterward, instrumentation may be autoclaved on site. Free wireless internet access is also provided.
FAILURE AND REGULATORY ANALYSIS Our facility has assisted more than 100 companies with their FDA submissions on over 500 medical devices. We collaborate with both regulatory and research and development departments with the end goal of designing and executing specialized, non-standard test systems that evaluate medical devices of various origin. With numerous mechanical testing frames, a wide range of load and torque cells, various diagnostic imaging capacity and three dimensional motion tracking systems, we are equipped to fulfill your biomechanical testing needs (including cadaveric).
3RD PARTY DEVICE ANALYSIS 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.
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