Cockpit Enterprise is a SaaS-based solution for medium to large medical device product development teams that integrates requirements management, test management, risk management data, and more, in a unified environment. Cockpit Enterprise is highly configurable and can be personalized to meet a company’s needs. It has a rich development framework that allows organizations to implement their Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a controlled and auditable environment. Ultimately, Cockpit Enterprise helps medical device manufacturers of Class II and Class III devices author, review, and approve the documents required for regulatory submissions and audits. Cockpit Enterprise is best suited for mature organizations that have established standard operating procedures and can dedicate the necessary resources to configuring and deploying the system.