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This recorded lecture, given by Charisse Green, Global Quality Expert, will help you discover the Medical Device Development Tools Program, this program is a way for the FDA to qualify tools that medical device sponsors can use in the development and evaluation of medical devices. -
Welcome to the Meditrial MDR Fundamentals. In three easy VIDEO-COURSES, you will learn all the essential information regarding the MDR changes and the new procedures for Clinical Evaluation and clinical trials, including a learning module on the new standard 14155. Get ready to learn all you need to know on the new European regulation for medical devices. After the courses, you can take a brief test to receive your certification. Enjoy! -
This lecture presents the roadmap of the new European regulation for 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. -
This lecture describes the key changes regarding post market surveillance 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 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. -
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.
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
