Clinical AI Governance Blog

Regulatory updates, governance guides, and industry analysis.

TGA's evolving approach to AI as a medical device

How the TGA classifies AI-powered clinical software, what Class I vs IIa vs IIb means for radiology, and how to prepare for coming changes.

March 29, 202614 min read

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Regulatory

RANZCR Chapter 9: What every practice director needs to know

RANZCR Chapter 9 sets binding AI governance standards for radiology. Section-by-section breakdown with compliance tips for practice directors.

Dr Reabal Najjar

Founder & CEO

March 15, 202612 min read

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Regulatory

TGA SaMD compliance: what radiology practices actually need to do

The TGA's regulatory framework for AI as Software as a Medical Device is complex. A practical breakdown of what applies to your practice and what is the vendor's responsibility.

March 5, 202614 min read

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