Conquer , ISO, and Notified Body Audits with Confidence

Streamline your prep, reduce findings, and achieve compliance excellence with Audit.Coach. Our AI-powered platform offers expert guidance and automated tools to help medical device companies manage all aspects of audit readiness.

Effortless Compliance, Powered by AI


Are you a medical device startup or SMB dreading your next audit? 

Do the ever-changing FDA, ISO 13485, and EU MDR regulations feel overwhelming? 

KoalaT.ai’s Audit.Coach is here to help you navigate those complexities and achieve audit readiness with ease.

Our AI-powered platform provides expert guidance, automated tools, and a secure space to manage all aspects of audit preparation. We’ll help you streamline your processes, reduce audit findings, and build a robust quality management system that exceeds expectations.


What Our Clients Say

Our Services

Effortless Compliance

Achieve effortless compliance with FDA, ISO 13485, and EU MDR regulations. Build a robust quality system and minimize risks.

AI-Powered Risk Management

Proactively identify and mitigate potential audit risks before they become costly problems with our AI-powered solutions.

Audit Preparation & Support

Conquer FDA, ISO, and Notified Body audits. Streamline preparation and achieve compliance excellence with confidence.

Audit Checklist Generator

Streamline your audit preparation with our AI-powered checklist generator. Ensure compliance with FDA, ISO, and EU MDR regulations effortlessly.

CAPA Assistant

Resolve issues efficiently with our CAPA Assistant. Transform complex problems into clear, organized solutions with ease.

Supplier Quality Guardian

Ensure the highest quality and compliance in your supply chain with our Supplier Quality Guardian. Trust in our AI to safeguard your operations.

Pricing Plans

Unlock exclusive compliance solutions tailored for your medical device needs.

Basic Compliance Audit

$500 - $1, 000

Ideal for companies starting their compliance journey.

Advanced Compliance Solutions

$200/hour - Custom Pricing

For businesses needing ongoing compliance support.

AI-Driven Compliance Solutions

Custom Pricing

Bespoke AI solutions for optimized compliance.

Contact Us

Phone: 747-333-6955
Email: KoalaT@KoalaT.ai
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