Clinical Evaluation under EU MDR 2017/745 E-Learning Course
•Describe the new and key requirements and expectations for Clinical Evaluation under the EU MDR
Who Should Attend?
The Clinical Evaluation course is designed for employees of a medical device manufacturer, specifically for those working in quality assurance or regulatory affairs, and service providers to the industry.
Objectives
The Clinical Evaluation course is part of a modular concept under the MDR Expert Certification Program. The Clinical Evaluation of medical devices is a critical element of the European CE marking regulation. Through this self-paced course learners will gain an understanding of the key requirements including planning and implementation for Clinical Evaluation under EU MDR. Join us in a transformative journey!
Agenda
- Evaluation of Clinical Evaluation
- Purpose of Clinical Evaluation
- Planning and Implementing the Clinical Evaluation Process
- Overview of concepts
- State-of-the-Art (SOTA)
- Clinical Evaluation Plan (CEP)
- Clinical Development Plan (CDP)
- Clinical Evaluation Report (CER)
- Conducting literature search
Methodology
The course employs a variety of training tools such as content-embedded assessment, animations, and other interactive exercises to enhance instructional delivery. Easily accessible via your preferred choice of device, the course allows you to log in and learn whenever, wherever.
FAQs
TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Academy UK offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Academy do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us.