FDA's Medical Device Software Regulation Strategy

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  • Published date: October 28, 2020
    • Virtual Seminar, california, United States



The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated.

How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump?
Can one software program defeat the performance capability or back up safety features of another software program?
When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?

This seminar will focus on addressing these concerns and educating participants on FDA’s recent medical device software regulation strategies.

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Ashutos Swain
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