Medical Affairs is a department within Global R&D focusing on supporting product development and our markets. The Medical Affairs organisation contains the following functions:
Clinical Operations - responsible for the planning and conducting of clinical studies as well as to establish the clinical documentation required to demonstrate performance, market claiming and business needs.
Regulatory & Scientific Affairs - responsible for scientific evaluations, reporting and publication of clinical studies and regulatory support to innovation projects as well as to establish the product documentation package required for regulatory approval.
Design Control - responsible for the creation of required design control documentation for innovation projects.