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My Software Is a Medical Device (SaMD). Now What?
Moderated by Jama Software, BeanStock Ventures alongside the past and present members of the FDA will address some of your most pressing challenges.

With the rapid innovation in digital health such as clinical web and mobile software applications which do not traditionally classify as a “device” due to its lack of custom electromechanics, the Software as a Medical Device guidance (SaMD) was adopted by the FDA along with global regulatory leaders to ensure such software products adopt the same general medical device principles to demonstrate safety, effectivity and performance. The creation of SaMD was heavily influenced by new entrants unfamiliar with medical device regulations and terminology developing a broad spectrum of applications in order to support the new and growing industry.

Aug 25, 2020 11:00 AM in Pacific Time (US and Canada)

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