What is considered a Medical Device?
This course provides a summary review of where to start in deciding which directive a product will fall under and whether it can be considered as a medical device. The course provides examples of what may be medical devices in case of borderline products.
Upon completion of this course, trainees will be able to correctly and successfully:
- Comprehend the mechanisms of the different directives applicable to medical devices and recognize the fact that some products may fall under different classification systems.
Professionals new to the medical device industry, whether inventors, managers, CEO’s or professionals wanting to get an initial understanding of which regulatory system their product may fit under.