Sometimes, navigating the world of regulations can feel like manoeuvring through a complex labyrinth. One of the first and arguably most crucial steps in this process is determining the classification of your device. Though this essential task appears straightforward, it carries significant implications, guiding your product’s trajectory to reach the market.
The classification of medical devices is not just about assigning arbitrary labels; it revolves around a risk-based methodology focused on the potential effect a device might have on patient health and safety. Globally, regulatory authorities, including the US Food and Drug Administration (FDA) and the European Authorities, utilize comparable structures to sort devices according to their intended use, degree of invasiveness, duration of use, and potential for harm.
Discover how to navigate the medical device classification and how to shape your regulatory journey. Read the whole article here: MEDICAL DEVICE CLASSIFICATION: NAVIGATING THE REGULATORY MAZE.
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