Quality and Regulatory Affairs professionals are not the only one responsible for regulatory strategy , but it is a company issue. Potentially, all functions might be involved in the process, since all devices’ aspects must be considered. The regulatory strategy completion may involve R&D (in particular R&D managers and Project Team Leader),chemistry, engineering, toxicology, biology experts etc. depending on the device type, Regulatory Affairs, marketing and registered office. Let’s not forget the Top Management, that is the function that must make balanced and informed decisions.