PCCP
FDA COMPLIANCE
JUNE 24, 2026
6 MIN READ
What a Credible PCCP Actually Requires — And Why Most MedTech AI Companies Get It Wrong
FDA has now authorized over 1,350 AI-enabled medical devices. Almost every one of them needs a Predetermined Change Control Plan. Most companies have written one that satisfies the submission requirement but will not function as actual governance when something drifts. Here is what a credible PCCP actually requires — and where the gap almost always lives.
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// PCCP READINESS INDICATORS
AI COMPLIANCE
MEDICAL DEVICE
FINANCE
DEFENSE
JULY 7, 2026
8 MIN READ
Independent AI Model Evaluation for Medical Device, Financial, and Defense Organizations
ClearanceAI evaluates AI tools against FDA 2025 AI Guidance, SR 11-7, DoD AI Ethics Principles, and NIST AI RMF. A complete guide to benefits and use cases across the three primary regulated industries we serve.
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AI COMPLIANCE
INDEPENDENT EVALUATION
JULY 17, 2026
7 MIN READ
Independent AI Assessment Is Not All the Same — What Regulated Industries Need to Know Before Choosing One
More organizations are now offering independent AI assessment. But for regulated industries, not all assessment produces the same documentation. Here is the critical difference — and three questions to ask any provider before you choose.
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BIAS DOCUMENTATION
FDA COMPLIANCE
CMS
AUGUST 9, 2026
7 MIN READ
What FDA Means by Demographic Bias Documentation — And What Most Internal QA Misses
94% accurate overall can still fail one patient population significantly. FDA requires subgroup-level performance documentation across age, sex, race, and geography — reviewed by an independent credentialed clinician. Here is what the standard actually demands and where the gap almost always lives.
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