AI Compliance Intelligence for Medical Devices
AI COMPLIANCE FOR MEDICAL DEVICES
Continuous
Compliance Intelligence for MedTechs
Instantly assess regulatory compliance for your medical device documentation. Identify gaps, risks, and next steps with expert trained AI-powered analysis—secure, private, and always up to date.
Need deeper review? We seamlessly connect you to our specialized network of compliance experts.
Expert-Grade Compliance
Privacy-First Architecture
Built for MedTechs
🟢 Now collaborating with regulatory and compliance experts
Lead MDR Auditor, Berlin
“CertMD significantly reduces manual compliance workload and helps teams maintain submission-ready documentation at all times. It brings much-needed structure and traceability to MDR processes.”
MedTech CEO, Barcelona
“CertMD has fundamentally accelerated our path to certification. What used to take months of coordination and documentation is now streamlined into a predictable, scalable process.”
Regulatory consultant, Berlin
“With CertMD, we spend less time managing documents and more time delivering real regulatory insight to our clients.”
From raw documentation to audit-ready compliance in minutes
How it works
Upload your existing documentation and structure it in a unified compliance workspace.
CertMD analyzes and links requirements across EU MDR, UKCA marking, and international frameworks.
The system highlights missing elements, inconsistencies, and risks.
With one click, generate complete, audit-ready reports.
Upload
Upload Device Documentation
Any Format, any stage, any documentation
Step 02
Choose regulatory Framework & Output
Choose applicable regulatory framework
Step 03
Wait for CertMD AI Compliance check
Line-by-line AI compliance checks with full traceability.
Step 04
Identify gaps, NCs & recommendations
Clause-by-clause breakdown with references and citations.
Step 04
Optional deeper compliance support
Instantly connect to our expert-network
Features At A Glance
Everything medtech teams need to stay compliant, from development to post-market
Everything medtech teams need to stay compliant in one place.
Dashboards, privacy controls, lifecycle tracking, and expert support when needed.
Built for end-to-end regulatory readiness.
🧠 Expert-Level Insight
AI agents analyze like auditors—interpreting context, not just keywords, to prepare your documents for final human review.
📊 Gap & Readiness Report
Visual dashboard with compliance score and suggested to-do list.
🧩 Lifecycle Support
Use CertMD from design phase to pre-market audits.
⚡ Instant Compliance
Upload your documentation and get pre-audit results in minutes.
🔒 Private & Secure
Data never stored — processed in encrypted, isolated AI environments.
🧩 Auditor Network Access
Complex gaps? One-click connection to our curated network of regulatory experts for hands-on support.
Your Data. Your Control.
Trusted by professionals. Protected by design.
CertMD is built on a strict privacy-first architecture.
No document retention. No third-party sharing.
All processing happens inside private, encrypted AI clouds.
Fully GDPR compliant.
Zero Data Retention by Design
Documents are never stored in CertMD systems. Data is processed in real time and immediately discarded after analysis. No persistence means no residual risk or attack surface.
Fully Isolated & Encrypted Execution
All communication is end-to-end encrypted and runs through private cloud environments. Analysis happens in isolated infrastructure with no exposure to public models or shared systems.
No Training, No Leakage, Full Control
Your data is never used for model training or improvement. Results are streamed securely, and you decide what to export and store locally. Full compliance-grade privacy by default.