Regulatory Strategy & Market Access | Intended Use & Master UDI-DI

Medical Device made Easy Podcast · Aug 20, 2026

Bringing a medical device to market requires more than achieving regulatory approval. The decisions made early in product development can influence classification, clinical evidence, risk management, labeling, identification, and ultimately the entire market access strategy.

In this Easy Medical Device podcast collection, we focus on two important regulatory topics: defining a proper Intended Use and understanding Master UDI-DI.

Intended Use: The Foundation of Your Regulatory Strategy

Intended Use may look like a simple statement, but it can influence almost every part of a medical…