John SullivanDirector of Quality and Regulatory Affairs – Operations
John has been in the medical device field for 25 years. He has served as the quality and regulatory leader for a number of innovative device firms. In these roles, he obtained regulatory approvals for devices in the USA, Australia, Canada, and the European Union. He has led the implementation of ISO 13485 and GMP compliant quality systems and successfully undergone multiple FDA, Health Canada, and Notified Body inspections.
In addition to his success in quality and regulatory, John also founded two device companies that licensed their technology to Fortune 500 companies. During his career, he has helped to bring over thirty device platforms to market. He holds multiple patents for orthopedic implants and the treatment of ischemic neurological injuries. When he is not busy developing devices, you will find him trying to find an outdoor adventure with his family.