Contents page

1. Introduction

2. Latest regulatory news

3. Previous and forthcoming publications

4. Basic information for in-house software developers

5. The strange case of COTS and SOUP

6. Mobile medical apps

7. Clinical decision support (CDS) software

8. What about spreadsheets?

9. Current thinking on regulation of medical device software and AI

10. References

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This page was last updated: 25 Sept 2025