Latest / Medical Device made Easy Podcast
How can a proper Intended Use save your device?
A medical device’s intended use is not just a regulatory formality — it is the foundation of the entire product strategy.
In this podcast episode, Monir El Azzouzi speaks with Karandeep Badwal about how intended use influences classification, clinical evaluation, risk management, labeling, and ultimately market access.
The discussion explores why many companies underestimate the importance of intended use and how poorly written statements can create major downstream regulatory problems. From Software as a Medical Device (SaMD) to AI-driven products, the episode highlights real-world examples…
The skinny
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