Orthopedic Implant Testing: Fatigue Durability Wear Computational
Section 7 Testing LLC (S7T) specializes in orthopedic implant testing, providing fatigue, durability and computational protocols satisfying international testing standards. S7T has expanded to twelve testing stations, allowing decreased testing timelines. Computational testing offers many predicate results often halving testing budgets and includes contact area and material stress, range of motion, and F1223 knee constraint simulation, all accepted by the FDA. Consulting services include physical test design and virtual product development. Virtual tests can be rapidly employed to establish worst case testing conditions and the effects of component design and surgical procedure on clinical performance.
Section 7 Testing has over 30 years of experience generating reports that sail through regulatory agencies such as the USFDA. Standards testing, custom testing, and advanced computational product development are our specialties.
Most clients need a battery of tests to clear a single implant. S7T offers bundle pricing on combined mechanical, wear, and computational programs by anatomy.
The company is led by Ed Morra, MSME, who worked for three decades at the former Orthopaedic Research Laboratories, Inc. (ORL) as Manager of Computational Testing. Mr. Morra brings extensive expertise in building and leading computational testing programs that have supported more than 60 FDA 510(k) clearance submissions as primary evidence of device safety and efficacy. His background includes developing and validating nonlinear FEA and kinematic simulation protocols accepted by the FDA as evidence of safety and efficacy. Additionally, he has directed cross-functional teams through complete product development cycles—from requirements definition and design analysis to research, development, verification testing, and comprehensive documentation. His professional distinctions include over 40 peer-reviewed publications and two AAOS Award of Excellence commendations.