Medical devices are a wide range of products where In-Vitro Diagnostics are included. that require carefully planned and executed regulatory affairs strategy and quality assurance activities before it can be available in the marketplace. With the transition from In-Vitro Diagnostic Directive (IVDD) to In-Vito Diagnostic Regulation, the requirements when it comes to generating the required clinical evidence have increased. RegSmart Life Sciences can not only support you in developing a clinical development strategy for your IVD device, but also help you develop a cost-efficient regulatory plan and build and implement the required quality management system.