We welcome you to our high-quality eLearning course Introduction of the requirements of the Medical Device Industry.
This course provides you with an overview of the relevant terms and terminology in the medical device sector. You will learn the basics of medical device law, gain insights into the steps involved in a conformity assessment and CE certification, and understand how different areas such as technical documentation, risk management, quality management, etc. work together and interact.
This eLearning gives you the opportunity to build a fundamental understanding of working in this important industry.
Why should you choose our eLearning course?
- Industry-specific expertise: Our course was developed by experienced professionals in the medical device sector to ensure that you gain practical, relevant knowledge.
- Flexible eLearning: Learn at your own pace and in the location of your choice. Our eLearning approach allows you to optimize your schedule while still receiving high-quality training content.
- Interactive modules: Boring theory is a thing of the past! Our interactive modules deliver knowledge in an engaging and practical way. From case studies to quizzes – you will be actively involved in the learning process.
- Certificate for your career: After successfully completing the training, you will receive a certificate that confirms your qualification.
- Content
- Introduction
- Overview of the MDR structure
- Market approval of medical devices: The path to CE marking
- General obligations of manufacturers
- Person Responsible for Regulatory Compliance (PRRC)
- Post-Market Surveillance (PMS) and vigilance
Note on your personal learning environment:
After registering, you will receive access to our LMS platform so that you can view the course flexibly at any time. After completing the e-learning course, you will receive a certificate of qualification. - How you benefit
- In-depth knowledge: Gain a comprehensive understanding of the fundamental terms and processes in the field of Regulatory Affairs, providing you with confidence and competence in your professional environment.
- Flexible scheduling: You have 180 days to complete the eLearning at your own pace – ideal for balancing learning with your professional responsibilities.
- Career development: With the course certificate, you can demonstrate your newly acquired knowledge and skills, thereby enhancing your career opportunities in the medical device and regulatory affairs sector.
- Methods
Trainer input, tasks, case studies, storytelling.
- Target Audience
- Professionals new to the industry or career changers
- Regulatory Affairs specialists
- Quality Management specialists
- Employees from other departments who want to gain a better understanding of the overall picture and interfaces with other areas
