-
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. -
Viaggio nel mondo delle Tecnologie Medicali e Digital Health.
L’Università degli Studi di Roma Tre e Meditrial presentano una giornata dedicata al mondo dei Medical Device all’interno del Master Sociosanitario. Le testimonianze di esperti, protagonisti nel settore sanitario, socio-sanitario e socio-educativo, racconteranno l’evoluzione del panorama globale in ambito MDR a livello clinico e regolatorio. -
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders. -
Pharmacovigilance is required through the entire life cycle of a drug – starting from preclinical development stage, going through continues monitoring till regulatory approval as well as spanning post-market stidues. Discover with Meditrial all aspects of European Pharmacovigilance and Drug Safety that include collecting, analyzing, monitoring, and preventing adverse effects in new drugs and therapies. Upon completing a course, you will take a final test to receive a digital certificate that can be printed. -
Discover the world of innovation and medical standards made easy, learn about the brand new ISO 22679 draft standard for cardiac occluders. -
This course describes key principles of general safety and performance requirements. In this video we will discuss in detail article 56 of IVDR and will give practical advices on how to plan and prepare for the IVDR. Finically, we will explain what is the performance evaluation and which periodic deliverables and when need to be updated accordingly.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
