Training & Education in Ohio

JALEX Medical is a medical device engineering, design, and product development consulting firm headquartered in Westlake, Ohio. Founded in 2012, the company specializes in end-to-end support for Class I and Class II medical device development, from concept through FDA clearance and commercialization. With a team of 22 biomedical engineers and regulatory specialists, JALEX delivers integrated expertise in medical device design, regulatory affairs (510(k), PMA, De Novo, CE marking, Health Canada), quality management systems (ISO 13485, FDA 21 CFR Part 820), design controls, risk management (ISO 14971), and project management. The firm has completed 500+ projects across 20+ medical specialties including orthopedics, spine, cardiology, pediatrics, gynecology, and trauma. JALEX is known for comprehensive support, including project rescue services for troubled programs, and serves clients from startups to Fortune 500 manufacturers. The company has achieved 60+ 510(k) and De Novo clearances and emphasizes cross-functional collaboration, regulatory strategy alignment, and rapid market entry.