• We provide a turn-key approach for the evaluation of medical devices from the proof of concept stage to commercialization.

  • Our staff of highly qualified engineers and PhDs have over 25 years of research and testing experience.

  • Our purpose is to guide medical device companies in the areas of regulatory and pre-clinical test strategies for FDA and CE submissions.

 

Services

OrthoKinetic Technologies, LLC.  (OKT) and OrthoKinetic Testing Technologies, LLC.  (OKTT)  are two separate companies that provide a turn-key approach to the medical device industry.  Together, the two companies can assist in taking a medical device from concept to commercialization.

 

OrthoKinetic Technologies, LLC.  (OKT) is a consulting firm that provides the Client with regulatory and test strategies, protocol development, risk assessment and risk mitigation plans, performance and failure analyses, product management, and assessment of new technologies.


OrthoKinetic Testing Technologies, LLC.  (OKTT)  is an  ISO/IEC 17025:2005 , A2LA accredited medical device and tissue test facility that can perform a multitude of device testing and validation services.


Who We Are

We are a team of highly qualified PhDs and professional engineers with over 25 years of research and testing experience that specialize in mechanical device testing and evaluation.

We are regulatory specialists that strategize the proper pathway for successful FDA and CE submissions, mechanical, electrical, and biomedical engineers and material scientists with expertise in conventional and novel materials, failure analyses, particulate generation, and particulate characterization.

Events & Speaking Engagements

We speak at a number of events around the country. View our upcoming events to find out where we’ll be next.

Downloads & Printables

Click the links below to view each PDF file, right-click to save to your computer, or view and print for a physical copy.

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Explore our Services

Consulting Services

Testing Services

Additional Services