12,000+ |
8,000+ |
100k+ |
DEVICE COMPANIES |
REGULATORY CERTIFICATES TRACKED |
DEVICES PLACED ON THE |
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Streamline the first step to market access with device classification and verification | Quickly, easily create MDD / MDR / IVDR documents and FDA 510(k) submissions | Simplify your work, avoid missed renewals, and save time with automated registration and certification tracking |
Regulatory Watch |
Regulatory Intelligence |
Regulatory Pathway |
Keep track of regulatory changes and how they impact your registrations | Plan your expansion with process charts and FAQs comprising a global knowledge base |
Explore new markets with regulatory insights categorized by country, device type, and device class |
Emergo by UL
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Digital Health & Cybersecurity |
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Human Factors
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Bring safer products to markets worldwide and maintain compliance – even if your device is novel or high-risk. | Meet regulator expectations and reduce your risk of threat with Emergo's digital health & cybersecurity assessments. | Learn how Human Factors can help make your products safer, more effective, and easier to use. |