√ ivdr 243431-Ivdr requirements
All IVDR Services With 40 years of experience as a provider of testing services for the safety and quality of in vitro diagnostic medical devices (IVD), we are a competent partner for transitioning to the IVDR In addition, we support manufacturers of IVD and medical devices with market access services into the European and international marketsPrinted course presentation, a printed spiral bound book of the IVDR Regulation (EU) 17/746, a short test and a certificate is included for all participants Course Leader/s Emma Axelsson, Senior Quality and Regulatory Consultant AnnaKarin Areskog, Senior Quality and Regulatory ConsultantThe IVDR was put in force by the European Union on May 25, 17 as a replacement for the existing In Vitro Diagnostics Directive (IVDD) The EU has mandated a fiveyear transition period, so IVD manufacturers will have until May 26, 22 to comply with all the new requirements However, the IVDR is regarded as unprecedented in both the number Ivdr Resource Center Emergo...