Device Failure Evaluation

Researchers examine the failure of a medical device to determine the causes, whether they be defective design/manufacture, a surgical mistake, patient misuse, or failure to warn the user of known hazards.Researchers examine the failure of a medical device to determine the causes, whether they be defective design/manufacture, a surgical mistake, patient misuse, or failure to warn the user of known hazards.

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Investigation of Musculoskeletal Injury

Researchers investigate musculoskeletal injuries including but not limited to the knee, hip, shoulder, spine, foot, ankle, head, and neck to determine whether an injury has actually occurred and, if so, what the causes were.

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Test Protocol Development

Outcome of a bio-mechanics experiment depends on many variables. Type of loading, rate of loading, specimen , quality of test equipment and instrumentation, data collection method are some of the common variables which contribute in meeting deliverables of a bio-mechanics testing project. That is why it is very important to have a framework for successful execution […]

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510(k) submission

Any device manufacturer who wish to introduce class-II or certain types of Class-I and Class-III medical devices are required to get 510(k) clearance from FDA. As experts in the industry, we help you in evaluating device to comply with device-specific standards, prepare gap analysis, prepare 510(k) application, submission, answering follow-up questions from FDA. We provide cost-effective and […]

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Custom test equipment

We at Bluebay Research Inc., being in the bio-mechanics research for the past 30 years, understand the importance of having right equipment for the right job. Our expertise in broad range of engineering disciplines allowed us to build best in-class robotic testing machines which are automated, flexible and easy to use. We are experts in building […]

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Product Design and Development

Researchers design mechanical/electromechanical devices for musculoskeletal research or patient care. 510K preparation can be assisted. Researchers help focus a device’s design for patent application and evaluate the interference with existing patents. Researchers fabricate designs with both in-house 3D printing and CNC machining. In addition, Blue Bay Research partners with quality assurance machining and design are […]

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