What is MedReg AI?
MedReg AI is a regulatory compliance platform for medical devices, pharmaceuticals and dietary supplements. Its medical device regulation coverage includes EU MDR and FDA 510(k), alongside other device pathways. Users create a project, select the product type and target requirements, then upload supporting documentation. The platform performs AI gap analysis to identify missing requirements, assess compliance status and suggest actions for review.
The workflow combines document parsing, semantic search and evidence mapping. Findings connect to source pages and extracted passages, while readiness scores break results down by regulatory section and requirement category. Regulatory affairs teams can review prioritized recommendations and export PDF reports. The platform also covers drug submission pathways and supplement requirements, with cross-regulatory analysis for identifying shared requirements across jurisdictions.
Who it's for
- Medical device regulatory affairs teams
- Pharmaceutical submission teams
- Dietary supplement manufacturers
- Life sciences regulatory consultants
How to use MedReg AI
- 1
Define a project
Choose a device, drug or supplement, select the target regulations and define the submission pathway.
- 2
Upload supporting documents
Add technical files, clinical data, formulation records, labeling or other regulatory documentation.
- 3
Run the gap analysis
The AI compares the uploaded documents with applicable requirements and identifies gaps and compliance status.
- 4
Review findings and export
Inspect evidence citations and prioritized recommendations, then export a PDF report for review.
MedReg AI key features
Medical device regulation coverage
Supports analysis against EU MDR, EU IVDR, FDA 510(k), PMA, De Novo and ISO 13485 requirements.
Drug and supplement requirements
Covers NDA, ANDA and IND pathways, EU pharmaceutical regulations, and supplement topics including DSHEA, cGMP and new dietary ingredient notifications.
Document parsing and semantic search
Extracts content from PDFs, Word documents, spreadsheets and technical files, with semantic search across regulatory documentation.
Evidence mapping
Links findings to source documents through page references and extracted excerpts.
Compliance scoring and reports
Provides overall readiness scores and breakdowns by regulatory section and requirement category, with PDF report generation.
Cross-regulatory gap analysis
Identifies overlapping requirements to support documentation review across multiple jurisdictions.
MedReg AI use cases
EU MDR documentation review
Review medical device technical files and clinical documentation for gaps against EU MDR requirements.
FDA 510(k) preparation
Analyze supporting device documentation against FDA 510(k) requirements and review the resulting recommendations.
Pharmaceutical submission preparation
Check documentation for NDA, ANDA or IND submissions and trace findings back to supporting evidence.
Supplement regulatory compliance
Review formulation records and labeling against relevant DSHEA, cGMP and NDI requirements.
MedReg AI FAQ
What is MedReg AI?
MedReg AI analyzes life sciences documentation against regulatory requirements. It supports medical devices, pharmaceuticals and dietary supplements, producing gap findings, evidence references and recommendations.
Is MedReg AI free to try?
The site advertises a free initial analysis and says the first project does not require a credit card. Paid subscriptions are also available.
How do regulatory affairs teams use MedReg AI?
Teams select a product type and target regulations, upload documentation and run an analysis. They can then review cited findings and export a PDF report.
Does MedReg AI support EU MDR and FDA 510(k) gap analysis?
Yes. Both are listed among its medical device analysis pathways, alongside EU IVDR, PMA and De Novo.
What document formats can MedReg AI analyze?
The site lists PDFs, Word documents, spreadsheets and technical files. Examples of supporting material include clinical data, formulation records and labeling.
Can MedReg AI export regulatory compliance reports?
Yes. The platform generates PDF reports for internal review, regulatory submissions or investor presentations, and its findings include source-document references.
This introduction is based on the public pages of medical-regulation.com, read on October 9, 2026.