// Regulatory Insights

The ClearanceAI Blog

Written for MedTech founders, regulatory affairs professionals, and AI teams deploying into regulated industries. No hype. No generalities. Specific, actionable regulatory guidance from someone who has spent 20 years in this work.

EU MDR EU AI ACT CER September 27, 2026

What Clinical Evaluation Reports Are Missing About AI Compliance

CERs for AI-enabled medical devices are thorough on clinical evidence. Most are missing the one thing Notified Bodies are increasingly asking for — independent third-party evidence that the AI component meets EU AI Act, ISO 42001, and NIST AI RMF requirements.

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ISO 42001 NEW MEDTECH EU AI ACT AUGUST 24, 2026 8 MIN READ

ISO 42001 Is Now the Global Standard for AI Management — What MedTech Companies Need to Know Before Their Next Notified Body Meeting

ISO 42001 is the world's first AI Management System standard — and Notified Bodies are already asking about it in MDR audits ahead of the August 2027 EU AI Act deadline. Here is what the standard requires, how it connects to your existing ISO 13485 QMS, and what to do before your next Notified Body meeting.

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.

// PCCP READINESS INDICATORS

MONITORING SPEC

DRIFT THRESHOLDS

REVALIDATION PLAN

510(k) THRESHOLD

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 26-2, DoD AI Ethics Principles, and NIST AI RMF. A complete guide to benefits and use cases across the three primary regulated industries we serve.

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.

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.

MODEL RISK NEW MEDTECH FINANCE AUGUST 17, 2026 7 MIN READ

SR 26-2 Replaced SR 11-7 — What MedTech AI Companies Selling Into Hospital Systems and Payers Need to Know

On April 17, 2026, SR 26-2 superseded SR 11-7 — the model risk framework that has governed hospital and payer AI procurement for 15 years. Most MedTech AI vendors haven't updated their compliance documentation yet. Here is what changed and what to do before your next procurement conversation.