Streamline Your Medical Device Certification

Navigate regulatory requirements with confidence. Start by determining your device classification - it's free and takes just minutes.
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Comperhencive Guidance

Everything you need for medical device certification

Device Classification

AI-powered classification system determines your device class and applicable regulations.

Quality Management

Comprehensive QMS implementation guidance aligned with ISO 13485 standards.

Technical Documentation

Step-by-step guidance for compiling compliant technical documentation.

95%

Classification Accuracy

50+

Countries Covered

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Device Classification

AI-powered classification
Basic regulatory guidance
Market selection
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QMS implementation guidance
Technical documentation templates
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