OrthoKinetic Technologies, LLC

Overview

OrthoKinetic Technologies, LLC (OKT) is a regulatory and pre-clinical testing and advisory consulting firm. It provides regulatory guidance, assists with regulatory submissions, serves as a liason to the FDA and/or OUS regulatory agencies for domestic and international medical device companies. The company owner and additional OKT engineers have extensive experience in litigation support and forensic engineering and have served as expert witnesses in numerous brain and spine injury cases, product liability cases, including medical device failure analysis and testimony (DEFENSE ONLY).

OKT is the parent company of OrthoKinetic Testing Technologies, LLC (OKT2) which is an A2LA accredited test facility with accreditation for ISO and ASTM standardized tests in orthopedics and spine, and allograft tissue testing. It is one of the few accredited test facilities that is accredited for tissue testing. The engineers at OKT2 have extensive years of experience in this testing. Product testing and certification, sports equipment, textiles, toys, safety.

Standards & Methodologies

services include: to provide regulatory guidance, comprehensive preclinical strategies with test plans and the development of test protocols, prepare regulatory submissions, risk management assessment, provide scientific and biomechanical rationales and interpretations, provide project management for all preclinical studies including in vivo studies, biocompatibility assessments, and post-market studies. OKT can also provide preventative strategies for potential liabilities and can provide litigation support serving as medical device defense experts with ample experience in forensic engineering and legal testimony.

Qualifications, Certifications, Accreditations & Licenses

A2LA accredited for ASTM, ISO, and Human Tissue