Steps to CE Mark
This course provides a review of the different classification levels within the medical device directive in Europe including a review of the related regulatory requirements and regulatory routes possible to CE-mark. In this course we point out how important a quality system is and how a well designed quality system setup early on can help the manufacturer ensure compliance and improve efficiency. Last but not least the course emphasizes on the need for good documentation practices and that a technical file setup and maintenance throughout the lifecycle of a medical device is required.
Upon completion of this course, trainees will be able to correctly and successfully:
- Illustrate the CE-mark process and its major components:
- How a classification system under the medical device directive works
- How a manufacturer needs to decide which CE-mark route is appropriate for a particular device
- Importance of a well designed quality system
- Comprehend the technical file and the difference with STED as a global system.
Professionals new to the medical device industry, whether inventors, managers, CEO’s or business professionals in need to understand the elements of the CE-mark process.
Understand what a medical device is and how to determine that a product can be considered as a medical device. Understanding of the different phases of the medical device lifecycle will help with this course as well.