MedAd Compliance AI

MedAd Compliance AI helps medical writers, regulatory affairs professionals, and medical device manufacturers produce compliant regulatory and marketing content faster — combining the speed of generative AI with the regulatory rigor the medical device and pharma industries demand.

Writing medical marketing copy, Clinical Evaluation Reports, or Post-Market Clinical Follow-up plans is slow and high-stakes. A single non-compliant claim can trigger FDA warnings or EU MDR violations, and a poorly drafted CER can delay a device's entire regulatory pathway. MedAd Compliance AI is built to reduce that risk while speeding up first-draft creation.

HOW IT WORKS

Compliance Generation Console — Enter a raw product or treatment description, select a medical category, and choose a target compliance framework (FDA Advertising Guidelines, EU Medical Device Regulation, or Patient-Friendly Translation). The app generates and audits marketing copy against that framework, flagging non-compliant claims before they reach a reviewer.

CER & PMCF Generator — Enter core device details (name, manufacturer, MDR classification, therapeutic area, intended purpose, technical characteristics, equivalent device, known residual risks), and generate a structured, MDR 2017/745-aligned draft: a 10-section Clinical Evaluation Report (CER) or a 5-section Post-Market Clinical Follow-up (PMCF) Plan.

Audit Trail — Every generated output includes a transparent, step-by-step compliance report highlighting flagged terms, the specific regulation referenced, and safer alternative phrasing — so reviewers can see exactly why something was flagged.

WHO IT'S FOR

Built for medical writers, regulatory affairs professionals, and small-to-mid-size medical device manufacturers who need a faster, regulation-aware first draft for CER, PMCF, or marketing compliance review — without sacrificing rigor.

WHY IT MATTERS

Generic AI writing tools produce fluent text with no understanding of FDA or EU MDR requirements, and no built-in safeguards against medical hallucinations. MedAd Compliance AI embeds those regulatory guardrails directly into the generation process, aiming for a faster path from raw input to an audit-ready draft — cutting hours of manual cross-referencing against regulatory frameworks.

IMPORTANT: MedAd Compliance AI is a drafting and compliance-screening tool only. All generated content is a starting draft and must be reviewed, verified, and approved by a qualified regulatory or medical professional before use in any submission, publication, or marketing material. The app does not provide legal or regulatory advice and is not a substitute for professional review.