How I Built an AI Tool for Medical Device Regulatory Compliance

#ai #healthtech #startup #showdev

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).

Manual review is slow, expensive, and error-prone — even small gaps can delay approval or trigger regulatory findings.

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.

You can try it here: https://ileana-mazilu.lovable.app

Would love feedback from anyone in medtech, regulatory affairs, or healthtech!