About This Course

This course on European regulations for medical devices informs participants about all essential rules and regulations applicable in Europe regarding medical device development and usage. It ensures that participants not only comply with these standards but also understand their responsibilities and the implications of these regulations. This course aims to deepen understanding of the various regulations including ISO standards and other local norms relevant to medical devices, fostering proficiency in navigating this complex legal terrain.

At a Glance

• Institution: DelftX
• Subject: Health & Safety
• Level: Introductory
• Language: English
• Video Transcript: English
• Prerequisites: Some affinity with medical devices or their design.
• Associated Skills: Research, Medical Device Development, Medical Devices, Health Technology

What You Will Learn

Participants in this course will learn to:

• Ensure the safety and efficiency of medical technologies and their applications.
• Utilize in-depth knowledge of laws and regulations pertaining to medical devices.
• Identify and evaluate risks associated with the development and use of medical devices.
• Propose design improvements to enhance safety.
• Effectuate safe and effective introduction of medical devices within clinical settings.

Course Syllabus

• Week 1: Introduction to Medical Devices Regulation - Basics and definitions, device classification, overview of CE conformity.
• Week 2: Development of Medical Devices - Detailed CE conformity procedures, focusing on Annex I with practical examples.
• Week 3: Risk Analysis - Incorporating standards like ISO14971 and ISO TR 24971, connecting to practical forensic engineering methods.
• Week 4: Clinical Research - Covering ethical standards and regulations such as Art. 82, Annex XIV & XV.
• Week 5: Implementation of Medical Devices in Clinical Practice - Procedures for selecting, introducing, maintaining, and repairing medical devices, including custom device considerations.
• Week 6: Final Assignment and Wrap-up - Practical application of learning via classification and risk analysis of chosen devices; law and design quiz.

Who This Course Is For

This course is ideal for medical device professionals, engineers, and researchers involved in the design, development, implementation, and maintenance of medical devices. It also benefits regulatory professionals and healthcare providers who manage medical device portfolios in clinical settings.

Real-World Application

Knowledge gained from this course enables participants to play a crucial role in the medical device industry by ensuring all products meet the highest standards of safety and compliance. This competence is critical in reducing risks and enhancing the effectiveness of medical technology in healthcare settings, thereby contributing to higher standards of patient care and innovation in medical technology.