Learn how to develop the best approval strategy for your IVD
The most important requirements for the successful market entry of your IVD are the regulatory strategy as well as your quality management system (QMS).Despite the fact that harmonization efforts are already taking place worldwide, manufacturers of in vitro diagnostics still need to familiarize themselves intensively with the approval details of the respective countries; costs and time-to-market of IVDs are also important factors that should be taken into account in your considerations.Our Regulatory Affairs and IVD team will provide you with detailed advice on country-specific approval requirements, support you in implementing the requirements, and provide contact with your official bodies (e.g. BfArm or FDA) - for successful approval on the estimated time.