Making Medical Devices Reality

Start-ups to large corporations - we can help with all aspects of Medical Device Development
Specializing in Spinal and Orthopedic Implants & Surgical Instrumentation
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About

We specialize in the design and development of surgical instruments and implants. Our team has decades of medical design, regulatory (FDA & MDR), operating room and manufacturing experience and advanced degrees. We tote ourselves on providing the best client experience by maintaining open communication, providing designs quickly, short lead times and realistic schedules for complex projects. The majority of our business comes from referrals, contact us today to find out why we so many of our customers keep coming back.

Services

Design, Engineering, Prototyping,  Manufacturing, Additive Manufacturing / 3D Printing (Metal & Polymer), Injection Molding, Quality Systems, Regulatory Submissions, MDR Technical Documentation preparation, etc.
Design & Engineering

We specialize in the design and development of single use and reusable surgical instruments and implants (i.e., orthopedic, spine, trauma, CMF, joint replacement and bone fixation).

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Manufacturing

Our partners are experts in all types of manufacturing, from quick turn prototypes to production manufacturing (Additive Manufacturing, Machining, Injection Molding).

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Product Launch

We can help define and execute clinical testing, engineering justifications, 510k submission and much more.

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Contact Us

Info@OneStopSurgical.com

314-494-0313

St. Louis, MO USA

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