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AIaMD and RWE

Keeping it Real-World: The importance of RWD and RWE for AIaMD.

Recent posts.

SaMD

How to simplify medical device certification with a product-first approach.

Requirements

Why crafting proper requirements is so important for your software medical device (and how to do so).

Clinical evaluation data

What are the three types of clinical evaluation data you need to certify a software medical device?.

Clinical benefits

From claim to confirmation: how to properly define clinical benefits for SaMD.