Thank you for subscribing!

You will receive a confirmation email shortly!

In the meantime, here are a few of our most popular articles:

• How to Plan MRMC and Standalone Studies for a 3-Month 510(k)

• Definitive Guide to AI/ML SaMD Ground Truthing

• Medical Imaging AI/ML Engineering Guide: Best Practices and Examples

• Design Inputs: Best Practices, FAQs, and Examples

• De Novo Requests for Diagnostic Devices: FAQs and Examples

• Medical Device Cybersecurity: Best Practices, FAQs, and Examples

• Medical Device SBOMs: Best Practices, FAQs, and Examples

• FDA Pre-Subs: Best Practices, FAQs, and Examples

• FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond

• Open Source Radiology Foundation Models: A Comprehensive Exploration

• Medical-Device Software Regulations: Best Practices, FAQs, and Examples