Emergo by UL The U.S. Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance. Once finalized, the guidance document updates would expand the Breakthrough Devices Program’s scope to include devices that will improve accessibility and promote health equity. Specifically, the draft guidance clarifies the considerations […]
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FDA sets steep increases for 2023 medical device user fees
Emergo by UL Medical device manufacturers and importers seeking to sell their products in the U.S. market can expect substantial increases in some FDA fees compared with those for 2022. The fee increases take effect at the beginning of FDA’s 2023 fiscal year, which began October 1, 2022. Notably, FDA is switching to a five-year […]
Emergo by UL, MedCrypt pair on cybersecurity
Emergo by UL and MedCrypt will jointly offer cybersecurity risk management and mitigation for connected medical devices and systems. Medtech and healthcare technology consulting group Emergo and healthcare cybersecurity developer MedCrypt said this week that they will refer prospective clients to one another and co-market their cybersecurity software solutions, consulting and risk management services to ensure clients understand […]
New EU technical documentation file builder from Emergo by UL
The MDR Technical Documentation File Builder is the latest tool added to RAMS – Regulatory Affairs Management Suite, our software-as-a-service platform for digital regulatory solutions. This feature offers step-by-step guidance on building documentation to EU MDR specifications. The MDR Technical Documentation File Builder: Guides users through creation of a Technical Documentation File References eQMS to seamlessly […]
Emergo by UL launches 510(k) Builder for streamlined US FDA medical device submissions
Emergo by UL, a global medical device and healthcare technology consultancy, has rolled out 510(k) Builder, a new subscription-based software tool to simplify and streamline medical device manufacturers’ FDA 510(k) submissions in order to obtain faster US market access. Available through Emergo by UL’s Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance […]