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Video: What if you had a window into FDA Clearances for improved regulatory intelligence & 510(k) prep?


Did you know? Navigator for Medical Devices has made 65,000 510(k) PDFs searchable by intended use, indications for use, and device description

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What is a 510(k)? In order to market a medical device, manufacturers must comply with the 510(k) section of the Food, Drug and Cosmetic Act. This requirement states that device manufacturers must register and notify the FDA minimally 90 days in advance of their intent to market a medical device. Known as Premarket Notification – […]

Webinar exclusive for Reed Tech Customers: Losing sleep over EU UDI? No worries, Reed Tech has you covered

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Why is UDI strategy so important? The unique device identification initiative for medical devices and in vitro diagnostic medical devices is now an international hot topic and how you, as a manufacturer, respond will affect your bottom line in the coming years. Regulatory UDI requirements started with the US, spread to the European Union, and […]

Webinar: Medical Device Unique Device Identification Challenges & Solutions

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Medical device manufacturers will earn about the known requirements of leading regulatory and commercial UDI adopters


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