Jude Shellito

PRINCIPAL QUALITY CONSULTANT

Jude Shellito is a Regulatory and Quality Executive Consultant with more than 40 years of experience in quality engineering and over 30 years in the medical device industry. Having supported 200+ companies—from start-ups to global manufacturers—he specializes in Quality Management Systems (ISO 9001, ISO 13485, MDSAP, 21 CFR 820/QMSR), FDA, EUMDR and ISO remediation, risk management, CAPA, supplier quality, and process validation across a wide range of device technologies.

Jude currently serves as the founder and principal consultant for MediSol Consulting LLC , where he leads complex global compliance projects and mentors quality professionals. His background includes leadership roles in orthopedic, cardiovascular, and spinal device manufacturing, consistently improving compliance, yield, and product reliability.

Known for his technical depth, practical approach, and ability to drive sustainable quality outcomes, Jude partners with organizations worldwide to strengthen compliance, reduce risk, and accelerate product success. 

For more information, please see his LinkedIn Profile.