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
KoalaT.ai's audit readiness expertise helped us identify potential gaps in our quality system and implement corrective actions before our FDA inspection. We sailed through the audit with minimal findings!
KoalaT.ai's AI-powered tools and guidance streamlined our audit preparation process. We were able to organize our documentation, train our team, and conduct mock audits efficiently, saving us valuable time and resources.
KoalaT.ai gave us the confidence and peace of mind to face our first ISO 13485 audit. Their expert guidance and personalized approach made the entire process less stressful and more successful. Highly recommend!
KoalaT.ai's AI agents are incredible! They can answer complex questions about regulations and provide up-to-date information in real-time. It's like having a compliance expert on call 24/7!
KoalaT.ai's approach to audit readiness is data-driven and strategic. Their AI tools helped us identify trends and potential risks, allowing us to make informed decisions and proactively improve our quality system.
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.
- Initial consultation to assess compliance needs
- Full compliance audit with detailed report
- Recommendations for corrective actions
Advanced Compliance Solutions
$200/hour - Custom Pricing
For businesses needing ongoing compliance support.
- Regular compliance audits and monitoring
- Custom solutions for quality management
- Continuous support for compliance updates
AI-Driven Compliance Solutions
Custom Pricing
Bespoke AI solutions for optimized compliance.
- Tailored AI-powered analytics
- Data-driven strategies for compliance
- Continuous optimization with real-time insights
Contact Us
Phone: 747-333-6955
Email: KoalaT@KoalaT.ai
Email: KoalaT@KoalaT.ai
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