AI-Powered Regulatory Compliance

Stay Compliant withEU MDR Regulations

Medbash.ai uses advanced AI to monitor regulatory changes, assess impact on your medical devices, and guide you through compliance requirements for EU MDR, MPDG, and German regulations.

99.9%
Uptime
500+
Devices Managed
24/7
AI Support
<3s
Response Time
Features

Everything You Need for Compliance

Our AI-powered platform handles the complexity of regulatory compliance so you can focus on innovation.

Impact Assessment

AI-powered analysis of how regulatory changes affect your specific devices with actionable recommendations.

Component Tracking

Track all device components and validate changes for regulatory compliance before implementation.

Bashi AI Assistant

Get instant answers to complex regulatory questions with our intelligent research assistant.

Ticket Management

Automated ticket generation with smart priority assignment and deadline tracking.

Real-time Alerts

Instant notifications when regulatory changes affect your devices the moment they are published.

Document Parsing

Automatically extract and structure key information from Bills of Materials and regulatory documents.

How It Works

Three Simple Steps

Get started with Medbash.ai in minutes and stay compliant with ease.

01

Add Your Devices

Import your medical device portfolio with classifications, components, and compliance documentation.

02

AI Analyzes Impact

Our AI monitors regulatory changes and automatically assesses which of your devices are affected.

03

Take Action

Review AI recommendations, generate compliance tickets, and update documentation with confidence.

Regulatory Coverage

Comprehensive EU & German Coverage

Stay compliant with the most important European medical device regulations.

MDR

EU MDR 2017/745

European Medical Device Regulation covering safety, performance, and clinical evidence requirements.

Real-time monitoring
MPDG

German MPDG

Medical Devices Implementation Act for German national requirements and market access.

Real-time monitoring
MPBetreibV

Operator Ordinance

German Medical Devices Operator Ordinance for installation, operation, and maintenance.

Real-time monitoring
Testimonials

Trusted by QA Professionals

"Medbash.ai reduced our compliance research time by 70%. The AI impact assessments are incredibly accurate."

S
Dr. Sarah Mueller
QA Director, MedTech GmbH

"Finally, a tool that understands the complexity of EU MDR. The Bashi assistant is like having an expert on call 24/7."

T
Thomas Weber
Regulatory Affairs Manager

"Component change validation used to take weeks. Now it's done in hours with full traceability."

J
Dr. Julia Schmidt
Head of Quality, Berlin Medical

Ready to Simplify Compliance?

Join medical device manufacturers who trust Medbash.ai for regulatory compliance. Start your free trial today.

No credit card required • 14-day free trial • Cancel anytime