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software system | regulatory focus | www.fda.gov | FDA | FDA website | maude database | software | regulatory | Graematter | Regulatory Intelligence

Regulatory Intelligence

How much time to you spend searching FDA’s website? Looking for predicates, collecting adverse event reports from the MAUDE database, searching for guidance documents, etc. I’m sure I don’t need to dig into the details, you have felt this pain too if you have spent any appreciable amount of time on the www.fda.gov. Albeit a great source of information, it is a complex web of blue pages, and it takes a very large amount of time (and money!) to find the information you are looking for.
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mHealth | mobile medical applications | submission | FDA | devices | medical device | Apps | AliveCor | software | predicate | mobile medical apps | EKG | 510(k)

Mobile Medical Applications - Community Bull-Dozers

Well how about that - software developers are making it easy on me to write this series with yet another 510(k) clearance announced this week. The latest in cleared mobile health devices? The AliveCor mobile heart monitor.
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