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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. -
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. -
This lecture presents the new European regulation for medical devices and provides an easy to learn overview of all the key changes. Learn all you need to know for a successful transition to the new legislative framework. -
This video lecture discusses the impact of COVID-19 on clinical trials, potential pathways and modifications needed to run a successful trial and how new technologies can assist in moving forward. -
LEARN FOR FREE This course will cover some basic concepts to review the reimbursement system and define the role of health economics and outcomes research and will focus on how to incorporate health economics in the market access strategy. -
In this training, you will learn what IDE means, and how to prepare and submit your application to the FDA. -
The goal of this presentation is to provide you with the essential elements for success and to teach you how to apply the information to your project. Navigating the regulatory process and planning clinical trials can be the most daunting aspect of running your start-up. -
This tutorial intends to provide the requirements for placing CE-marked Medical Devices on the European market according to the Regulation (EU) 2017/745 on Medical Devices (MDR).
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
CERTIFIED FOR MEDICAL TRAINING
CLINICAL TRIALS – DIGITAL PLATFORM
INFORMATION SECURITY – MEDICAL EDUCATION
