From the blog

Thoughts and insights from the Coauthor team on how to build Software as a Medical Device.

Why Compliance Matters: The Basics

In the rapidly evolving landscape of medical technology, compliance is often viewed through a dual lens: a gateway and a barrier. It is a critical checkpoint that can either accelerate a product’s journey to the market or halt it in its tracks

Rebecca Beausang

Rebecca Beausang

Independent writer

Navigating Regulatory Debt in SaMD

Regulatory debt can stop a medical device achieving market approval. What is regulatory debt and how can it be avoided?

Alan Parkinson

Alan Parkinson

Technical Director