We help our clients gain regulatory approval for hand, wrist, and elbow medical devices
We offer a broad range of static, dynamic, computational, and wear testing services for hand, wrist, and elbow medical devices. All of our test procedures follow international test standards as described below.
Our engineering team is active in ASTM and ISO arthroplasty standards committees to ensure the latest industry best-practices are applied to your test. If a non-standard test is needed, our engineering team will develop and incorporate modifications to suit your specific device and data needs.
Having a strong foundation in clinical research provides you with the additional value of a clinically-relevant test procedure. We pride ourselves on the ability to meet a customer’s specific needs with a wholly unique, tailored solution.
Specification for Articulating Total Wrist ImplantsDescribes the specifications for the radial and carpal components of articulating total wrist implants, including solid ceramic impalnts. Specifications pertaining to material, manufacture, performance requirements, dimensions, finish, markings, and packaging are covered. No ASTM standard for testing total wrist implants is available, however the OIC can develop a custom test method tailored to the device's intended use and applicable physiological loading conditions. | |
Specification for Total Finger Joint ImplantsDescribes the specifications for elastomeric flexible hinge finger total joint implants, used with and without metal grommets, exclusively intended for use in the proximal interphalangeal (PIP) and metacarpophalangeal (MCP) joints. Specifications pertaining to material, manufacture, performance requirements, dimensions, finish, markings, and packaging are covered. No ASTM standard for testing total finger joint implants is available, however the OIC can develop a custom test method tailored to the device's intended use and applicable physiological loading conditions. |