Contact: Ken Schmidt
Year Established: 1988
Key Clients: Zoll Medical, Abbott Laboratories, Gambro, Health & Life.Optim Associates is a global medical device consulting company with extensive experience addressing FDA 483s, warning letters, and consent decree actions. The company has expertise in quality systems auditing, development, and remediation and has specialized experience in CAPA, design controls, risk management, reliability, and program development.
