Cybersecurity: Planning for a Successful Premarket Submission

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Event Location

Location: Room 211AB


Event Information

Title: Cybersecurity: Planning for a Successful Premarket Submission

Event Type: Lunch & Learn


Description

Compliance with cybersecurity for medical devices is now law, and the FDA has requirements for this change. One of the biggest impacts is the “Security Risk Management Plan”, which used to be a simple document, but no longer!

This new plan will take days to create and has specific content required to be in this plan. During this presentation, we will review the required content and create an example Security Risk Management Plan that can be easily re-purposed for use in your project. If you are submitting a premarket submission this year, this presentation will save you time and money for an otherwise laborious task.


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