Resource Library for Medical Device Professionals

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Thinking about entering the US market for the first time? Understanding the FDA regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter the US market.view all

Market Data | 1 page

How long does it take the FDA to clear 510(k) submissions? We look at 5 years of data to identify trends.view all

Market Data | 11 pages

A brief look at the United States' medical device market, including potential opportunities and obstacles for manufacturers.view all

Market Data | 1 web page

Learn about the regulatory structure in the United States and major medical device regulations.view all

Market Data | 1 page

Learn about the FDA 510(k) process in this informative page from Emergoview all

Market Data | 1 page