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This lecture describes the key changes regarding post market clinical follow-up and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy! -
This video course presents the European Database for Medical Device and in vitro diagnostic device and provides key information in order to become familiar with the new electronic system for data storage. Learn all you need to know regarding the new Electronic database system! -
This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. Learn all you need to know for a successful transition to the new legislative framework. -
This lecture presents the roadmap of the new European regulation for in vitro diagnostic medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework. Easy guidelines are provided to get ready on time! -
The purpose of this tutorial is to analyze the MDR provisions for adverse events recording and reporting to Competent Authorities. The topics addressed are: MDR references, Relevant definitions, Sponsor obligations in case of adverse events occurring during the clinical investigation and Regulatory comparison: MDD vs MDR. -
This tutorial aims to provide an overview of the MDR provisions related to the end of the clinical investigation, along with an outline of the MDR rules concerning the extraordinary events which could happen during the clinical investigation (substantial modifications, corrective measures, temporary halt, early termination). -
Learn the new MDR rules for study application and approval process. The coordinated assessment procedure will streamline clinical investigations conducted in more than one EU Members State. -
This lecture investigates the new Medical Device Regulation (MDR) with regard to conditions, ethical principles, methods and informed consent process. The intent of this tutorial is to describe the conditions for carrying out clinical investigations and to outline the rules laid down by MDR for particular clinical investigation types. -
This course presents an overview of the "actors" within the scope of the new MDR, namely the sponsors, investigators, and subjects. Learn all you need to know about how these "actors" play a significant role within the new MDR. After the course, you can take a brief test to receive your certification. Enjoy! -
Learn the new definitions and types of trials contained in the MDR, understand when investigations are not required and much more.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
