In this short and practical course, you will learn more about the multidisciplinary Medical Device Regulation (EU-MDR) guideline. With the MDR toolkit you gain step-by-step insight into medical device regulation during the 3 phases of a clinical trial. In a case-based and attractive way, you will learn about real-time planning and the obstacles and challenges you will encounter during this process. After completion you are able to prove you gained the knowledge to participate in Medical Device trials and to be working completely EU-MDR (2017/745) and ISO 14155:2020 compliant.
A large part of this course is about the MDR which discloses every step in medical device trials, aiming to “establish robust, transparent, predictable and sustainable regulatory framework, which ensures a high level of safety and health whilst supporting innovation.” (MDR, 2017/745, I.1).
The aim of the course is to obtain foundational knowledge as well as refresh the basics of Medical Device Regulation (MDR). After successfully completing you will receive a certificate.
For whom
Investigator, CRA/Monitor, Research Coordinator, Sponsor/CRO staff, Medical Specialist.
At the end of the course, you have learned about:
– Medical device research
– What CE-certificates are an how to obtain them
– Differences between medicinal product law and the law for medical devices regarding clinical research
– How to determine safety and performance requirements
– Randomization
– Differences between MDR and MDD
– The Informed consent process
– Screening patients
– Developing treatment
– Reporting on the study
– Insurances
This course is divided in three different learning units:
1. The background and history of medical device research. This learning unit explains the motives behind the development of the international laws and regulations regarding medical device research, using historical facts as a basis.
2. Three Phases of a Trial involving a medical device. This learning unit introduces the three phases of a research trial: the preparation phase, the execution phase and the close-out phase, and the aspects of the medical device regulation that are in play.
3. Course Exam and Evaluation. The final learning unit contains an extensive overview and summary of all the previous materials in the course. In addition, it provides you with practical information regarding the exam. Completion of the course exam is compulsory in order to receive the official certificate issued by Elevate & Artimed.
In this course, you will encounter reading texts, informative graphics, instruction videos and practice questions. These questions are only meant to practice. At the end of the course you can take an exam to test your understanding. You will need to get a score of 70% or higher to pass the course and receive your certificate. Don’t worry if you don’t pass the first time, you can take the exam a maximum of three times.
You will receive a certificate upon completion of all required learning activities. Access to the course in the online learning environment will be granted for up to 1 year after enrollment into the course.
We believe that future-proof research is essential for good care. That is why we combine innovative medical knowledge with didactics. Thanks to our extensive network and proven didactic methods, we make Life Sciences and Health professionals better than yesterday.
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