European Medical Devices Regulation: Practical Application
Master EU medical device regulations in this 6-week course. Learn safety, compliance, and implementation for effective device development and usage.
Master EU medical device regulations in this 6-week course. Learn safety, compliance, and implementation for effective device development and usage.
This comprehensive course delves into the crucial regulations governing medical devices in Europe. Designed for professionals in the medical technology field, it provides essential knowledge for ensuring compliance and success in device development. Participants will gain in-depth understanding of European Medical Device Regulation, ISO standards, and practical applications. The course covers risk assessment, clinical research, and the safe introduction of medical devices into healthcare settings. By the end, learners will be equipped to guarantee safety and efficiency in medical technology, apply regulatory knowledge, assess risks, propose design improvements, and facilitate the effective implementation of medical devices in hospitals. This foundational knowledge is vital for anyone involved in developing, designing, selling, or utilizing medical devices in the evolving European regulatory landscape.
Instructors:
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What you'll learn
Guarantee safety and efficiency in medical technology development and application
Apply in-depth knowledge of laws and regulations for medical devices
Recognize and assess risks related to medical device development and use
Propose design improvements to enhance medical device safety
Establish safe and effective introduction of medical devices in hospitals
Understand CE conformity procedures for different device classes
Skills you'll gain
This course includes:
PreRecorded video
Graded assignments, exams
Access on Mobile, Tablet, Desktop
Limited Access access
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There are 6 modules in this course
This course provides a comprehensive overview of medical device regulation in Europe, focusing on practical application and compliance. It covers the European Medical Devices Regulation, CE conformity procedures, risk analysis using ISO standards, clinical research requirements, and the implementation of medical devices in healthcare settings. The course emphasizes the importance of safety and efficiency in medical technology development and application. Participants will learn to apply regulatory knowledge, assess risks, propose design improvements, and facilitate the safe introduction of medical devices into hospitals. The curriculum includes hands-on assignments and case studies to reinforce learning and practical application of concepts.
Medical Devices Regulation
Module 1
Development of Medical Devices
Module 2
Risk Analysis
Module 3
Clinical Research
Module 4
Introduction and Implementation of Medical Devices in the Clinic
Module 5
Final Assignment and Wrap-up
Module 6
Fee Structure
Instructors
2 Courses
Expert in Forensic Biomechanical Engineering and Medical Device Innovation
Arjo Loeve serves as a tenured lecturer in the BioMechanical Engineering department at TU Delft and coordinates the Co van Ledden Hulsebosch Center for forensic science and medicine. Since 2006, he has conducted research in clinical technology, expanding into forensic engineering in 2008. His Ph.D. research focused on rigidifiable shaft-guides for flexible endoscopes, while simultaneously improving trace collection methods for rape victims. His research encompasses two main areas: analyzing failures of medical-technological systems and trauma mechanisms, and developing forensic technology. His work as an expert investigator on bacterial outbreak cases has influenced worldwide changes in device design and hospital hygiene policies. Recent innovations include specialized forensic sample collection tools and contactless evidence photography systems. Through close collaboration with forensic institutes and the Dutch Police, he continues to advance the field of forensic engineering, while his role as a founder of the "TUDelft Forensics" community strengthens the connection between engineering and forensic science.
1 Course
Pioneer in Medical Process Engineering and Surgical Innovation
John van den Dobbelsteen serves as Professor of Medical Process Engineering at TU Delft since January 2023, while also holding positions at Leiden University Medical Center and Erasmus Medical Center. His academic journey began at the University of Groningen, where he graduated in Experimental Psychology in 1998, followed by a Ph.D. in Neuroscience from Erasmus MC Rotterdam. With 18 years of experience at TU Delft, he currently directs the Clinical Technology and Technical Medicine programs while serving on the board of the International Society for Medical Innovation and Technology. His research focuses on improving surgical workflow efficiency through innovative medical technology, particularly using artificial intelligence and camera systems to monitor operating theater activities. His work addresses the growing challenges of technological complexity in medical settings by developing systems that support surgical staff rather than focusing solely on procedures. Through his leadership in the Medical Delta NIMIT and Institute of Fetal & Neonatal Care programs, he continues to advance the field of medical process engineering, working to optimize surgical workflows and enhance the interaction between medical staff and technology.
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