- +49 241-51967486
- info@mec-academy.de
- Aachener-und-Münchener-Allee 9, 52074 Aachen
The goal of the ongoing certification course „Medical Writing for Medical Devices“ is to provide participants with a comprehensive understanding of the processes and documentation required for CE marking of medical devices, with a focus on the clinical component.
Participants will be equipped to independently create regulatory documents such as Clinical Evaluations and PMCF (Post-Market Clinical Follow-up) documents 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 the course, participants will be able to understand the key tasks involved in creating Clinical Evaluations and PMCF documents and implement efficient task management. The standards and required development steps are clearly outlined.
The implementation of the MDR on May 25, 2017, significantly increased the regulatory requirements for medical devices. This course addresses the need for a deep understanding of these new requirements, particularly in relation to clinical evaluation and the monitoring of medical devices throughout their lifecycle.
This course is aimed at individuals who are involved in or plan to work in the medical device field. It is particularly suitable for those who need to understand the regulatory requirements under the MDR, with a focus on clinical evaluation and post-market monitoring.
The course comprises 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 is designed to span six weeks.
The package includes:
You can start every first week of a month and benefit from comprehensive support and resources tailored to your specific needs.
The cost of the course is €950.
You will receive:
Start today and elevate your expertise in medical writing for medical devices!
Video: Kick-off
Weekly Assignment for Module 1:
Video: PICO analysis and State-of-the-Art research, as well as text creation
Weekly Assignment for Module 2:
MEC-ACADEMY GmbH
Aachener-und-Münchener-Allee 9
52074 Aachen
Tel.: +49 241-51967486
Mail: info@mec-academy.de
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