MedReg AI
Supporting EU MDR, FDA 510(k), NDA, ANDA and DSHEA

AI-Powered Regulatory
Intelligence for
Medical Devices 

AI-powered compliance platform for medical devices, pharmaceuticals, and dietary supplements. Upload documentation, receive instant analysis, identify regulatory gaps.

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Trusted by 500+ life sciences companies worldwide

medical-regulation.com/projects
MedReg AI Screenshot

Comprehensive Regulatory Coverage

EU MDRMedical Device Regulation
EU IVDRIn Vitro Diagnostic Regulation
FDA 510(k)Premarket Notification
FDA PMAPremarket Approval
FDA De NovoDe Novo Classification
FDA NDANew Drug Application
FDA ANDAAbbreviated New Drug Application
EU MDRMedical Device Regulation
EU IVDRIn Vitro Diagnostic Regulation
FDA 510(k)Premarket Notification
FDA PMAPremarket Approval
FDA De NovoDe Novo Classification
FDA NDANew Drug Application
FDA ANDAAbbreviated New Drug Application
EU MDRMedical Device Regulation
EU IVDRIn Vitro Diagnostic Regulation
FDA 510(k)Premarket Notification
FDA PMAPremarket Approval
FDA De NovoDe Novo Classification
FDA NDANew Drug Application
FDA ANDAAbbreviated New Drug Application
EU MDRMedical Device Regulation
EU IVDRIn Vitro Diagnostic Regulation
FDA 510(k)Premarket Notification
FDA PMAPremarket Approval
FDA De NovoDe Novo Classification
FDA NDANew Drug Application
FDA ANDAAbbreviated New Drug Application
FDA INDInvestigational New Drug
EMA MAAMarketing Authorization
FDA BLABiologics License Application
DSHEADietary Supplement Act
FDA NDINew Dietary Ingredient
FDA cGMPGood Manufacturing Practice
EU Food SuppFood Supplement Directive
FDA INDInvestigational New Drug
EMA MAAMarketing Authorization
FDA BLABiologics License Application
DSHEADietary Supplement Act
FDA NDINew Dietary Ingredient
FDA cGMPGood Manufacturing Practice
EU Food SuppFood Supplement Directive
FDA INDInvestigational New Drug
EMA MAAMarketing Authorization
FDA BLABiologics License Application
DSHEADietary Supplement Act
FDA NDINew Dietary Ingredient
FDA cGMPGood Manufacturing Practice
EU Food SuppFood Supplement Directive
FDA INDInvestigational New Drug
EMA MAAMarketing Authorization
FDA BLABiologics License Application
DSHEADietary Supplement Act
FDA NDINew Dietary Ingredient
FDA cGMPGood Manufacturing Practice
EU Food SuppFood Supplement Directive

What is MedReg AI?

MedReg AI is an intelligent regulatory compliance platform that analyzes life sciences documentation against regulatory requirements. Whether you're bringing a medical device, pharmaceutical drug, or dietary supplement to market, we identify compliance gaps and provide actionable recommendations.

Medical Devices

Medical Devices

Comprehensive analysis for EU MDR 2017/745, FDA 510(k), PMA, De Novo, and ISO 13485 requirements.

Pharmaceuticals

Pharmaceuticals

Full support for FDA NDA, ANDA, IND submissions and EU pharmaceutical regulations including EMA guidelines.

Dietary Supplements

Dietary Supplements

Navigate DSHEA, cGMP (21 CFR 111), structure/function claims, and new dietary ingredient notifications.

Cross-Regulatory Intelligence

Cross-Regulatory Intelligence

Identify overlapping requirements and streamline multi-jurisdictional submissions with unified gap analysis.

Why Leading Companies Choose MedReg AI

Transform your regulatory workflow with AI-powered intelligence that reduces costs, accelerates timelines, and minimizes compliance risk.

What typically takes weeks of manual documentation review can be completed in hours with intelligent AI analysis.

How MedReg AI Works

From documentation upload to actionable compliance insights in four simple steps:

1

1. Create Your Project

Select your product type (device, drug, or supplement) and target regulations. Define your submission pathway.

2

2. Upload Documentation

Upload technical files, clinical data, formulation records, labeling, and any regulatory documents.

3

3. AI Gap Analysis

Our AI analyzes every document against applicable regulatory requirements, identifying gaps and compliance status.

4

4. Review and Export

Review detailed findings with evidence citations, prioritized recommendations, and export professional reports.

Platform Capabilities

Everything you need to streamline compliance across medical devices, pharmaceuticals, and supplements.

Multi-Product Support

Single platform for devices (Class I-III), drugs (NDA/ANDA/IND), and supplements with product-specific intelligence.

Intelligent Document Parsing

AI extracts and understands content from PDFs, Word documents, spreadsheets, and technical files.

Semantic Search

Find relevant documentation instantly with AI-powered search across all your regulatory files.

Evidence Mapping

Every finding links directly to source documentation with page references and extracted excerpts.

Compliance Scoring

Get overall readiness scores with detailed breakdowns by regulation section and requirement category.

Professional Reports

Generate audit-ready PDF reports for internal review, regulatory submissions, or investor presentations.

Client Testimonials

See how MedReg AI is transforming regulatory compliance across the life sciences industry.

DS

Dr. Sarah Chen

VP Regulatory Affairs, Global MedTech

MedReg AI reduced our EU MDR gap analysis from 3 weeks to 2 days. The AI findings are remarkably accurate and saved hundreds of hours of cross-referencing.

MT

Michael Torres

Director of RA, PharmaCorp

We used MedReg AI for our NDA submission preparation and identified critical gaps in our clinical documentation that manual review missed.

DE

Dr. Emma Williams

Chief Quality Officer, NutraScience

For dietary supplement compliance, nothing else comes close. The DSHEA and cGMP analysis is comprehensive and the recommendations are actionable.

JP

James Park

Regulatory Consultant

I recommend MedReg AI to all my clients across devices, drugs, and supplements. It provides regulatory expertise available around the clock.

DL

Dr. Lisa Anderson

CEO, BioMed Startup

As a startup, we couldn't afford a large RA team. MedReg AI gave us enterprise-level compliance capabilities at a fraction of the cost.

RK

Robert Kim

SVP Quality and Regulatory, OrthoTech

The 510(k) analysis identified predicate device gaps early in our development cycle. We received clearance without a single additional information request.

Stay Ahead of Regulatory Changes

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Frequently Asked Questions

Common questions about MedReg AI

Have more questions? Contact our team

Ready to Transform Your Regulatory Workflow?

Start your gap analysis today. No credit card required for your first project.

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