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FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health

by on Mar 25, 2013

  • 86,638 vues

Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of ...

Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process. The report covers the current scope of regulatory oversight, device classification and premarket requirements for digital health companies creating regulated products. Digital health entrepreneurs that have successfully navigated the process offer pointers and best practices to startups.

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  • AnilKumar9 Anil Kumar, Co-founder at Self Employed Very useful. Lot of grey area in terms of applicability but looks like only was is to go through the process. Il y a 3 mois
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  • random-0ne random-0ne Nice deck, but you really should turn on 'download'. Making people save 26 images (which is still available, regardless) is just silly. Il y a 4 mois
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  • MaryClaireHerbertRN Mary Claire Herbert, R.N. very well done Il y a 9 mois
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  • MaryClaireHerbertRN Mary Claire Herbert, R.N. Impressive information Il y a 9 mois
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  • ExMedNav Expert Medical Navigation at Expert Medical Navigation Excellent presentation! Any sense of how much should be budgeted for investment in this type of process? Having specific regulatory expertise on staff for the length of time needed could add up. Thanks! Il y a 1 an
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  • DonnaCusanoNYC Donna Cusano, Marketing Excellent presentation and the tips are spot on. Wish my former company had this in 2008! Il y a 1 an
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  • dja9 dja9 Wonderfull presentation. and very usefull as the Regulation is moving. Many thanks.
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FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health Presentation Transcript