The latest articles on DEV Community by Ileana Mazilu (@ileanamazilu1). https://dev.to/ileanamazilu1 https://media2.dev.to/dynamic/image/width=90,height=90,fit=cover,gravity=auto,format=auto/https:%2F%2Fdev-to-uploads.s3.us-east-2.amazonaws.com%2Fuploads%2Fuser%2Fprofile_image%2F4038102%2F904ad60b-bc35-496b-a302-9aa41a6d28a9.png https://dev.to/ileanamazilu1 en Ileana Mazilu Mon, 20 Jul 2026 12:03:55 +0000 https://dev.to/ileanamazilu1/how-i-built-an-ai-tool-for-medical-device-regulatory-compliance-716 https://dev.to/ileanamazilu1/how-i-built-an-ai-tool-for-medical-device-regulatory-compliance-716 <p>After 20+ years in pharmacy and 3 years as a Senior Clinical Evaluation Medical Writer, I kept seeing the same problem: small and mid-sized medical device companies often lack large in-house regulatory teams, yet face the same compliance scrutiny as major manufacturers when preparing Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), and Periodic Safety Update Reports (PSUR).</p> <p>Manual review is slow, expensive, and error-prone — even small gaps can delay approval or trigger regulatory findings.</p> <p>So I built MedAd Compliance AI, combining my real-world EU MDR and ICH-GCP expertise with AI-powered document review. Unlike generic AI writing tools, it's grounded in actual clinical evaluation practice — flagging compliance gaps before submission, not after rejection.</p> <p>You can try it here: <a href="https://ileana-mazilu.lovable.app" rel="noopener noreferrer">https://ileana-mazilu.lovable.app</a></p> <p>Would love feedback from anyone in medtech, regulatory affairs, or healthtech!</p> ai healthtech startup showdev