Medical Device Design

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We have expertise in orthopedic implants and instruments, prosthetics, implantable devices, MEMS sensors, actuators, fluidics, and packaging. We can create CAD models and full sets of engineering drawings for your design ideas, and we can perform finite element analyses.

Intellectual Property and Patents

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We have expertise in patent searches, discovering “white space” for development of new IP, defining scope and limitations of existing patents, determining patentability of your concepts, and performing patent reviews for patent applications.

Reports and Regulatory Compliance

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Whether you want to comply with FDA or CE Mark guidelines and regulations, we can perform a thorough review of the literature, commercial websites, and databases to demonstrate how your device is substantially equivalent to other products on the market. We can also prepare your entire dossier to submit to the FDA or your Notified Body.

Prototyping and Testing

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We have an in-house lab for electronic and small-scale testing and have access to facilities to create functional prototypes and perform bio-mechanical testing.

Expert Witnessing

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We provide technical analysis and opinion to assist courts in reaching decisions. As a skilled expert witness in biomedical technologies and consumer products we get to the bottom of the most difficult cases.

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