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This course is specifically designed for individuals working (or aspiring to work) in the field of medical devices who wish to further their expertise in medical writing, especially for clinical evaluation. The course provides weekly online training sessions and includes practical exercises where participants create regulatory documents relevant to approvals.
Participants will have an overview of the individual tasks involved in clinical evaluation and will be able to complete these tasks independently.
The aim of the ongoing certificate program "Medical Writing for Medical Devices" is to provide participants with a comprehensive understanding of the processes and documents required for CE marking of medical devices, with a focus on the clinical part. Participants will be equipped to independently prepare approval documents such as clinical evaluations and PMCF documentation to meet the complex legal requirements of the new Medical Device Regulation (MDR) 2017/745. Medical devices and medical software must comply with national and international laws and standards. After completing the course, participants will understand the key tasks in preparing clinical evaluations and PMCF documentation and will be able to implement efficient task management. Relevant standards and development steps are clearly presented.
With the implementation of the MDR on May 25, 2017, the requirements for medical devices have become significantly more stringent. This course addresses the need for a deep understanding of these new requirements, particularly concerning clinical evaluation and the ongoing monitoring of medical devices throughout their lifecycle.
The course is aimed at individuals in positions such as Regulatory Affairs or Quality Management (QM) managers with prior experience who want to deepen their knowledge, as well as newcomers and those transitioning into medical writing from other fields. A first professional degree in relevant fields is required.
The course consists of six modules, starting with an online training session introducing MDR 2017/745, followed by practical exercises for creating a Clinical Evaluation Plan. The entire program spans six weeks.
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Jumpstart your career in medical writing with a robust understanding of regulatory requirements and practical tools!
