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R&D Workshop: Medical Device Cybersecurity - Manufacturer Approaches
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4/11/2017
When: Tuesday, April 11 2017
7:30am - Registration & Breakfast; 8:00am program
Where: NITA Training Center
1685 38th St
Suite 200
Boulder, Colorado  80301
United States
Contact: Tracey
(303) 592-4088


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There continues to be a lot of discussion and concern regarding the FDA Cyber Security guidelines for Medical Devices among designers and manufacturers of complex medical devices.

Two of the primary FDA guidance documents are: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices and Postmarket Management of Cybersecurity in Medical Devices. The Premarket guidance was issued on October 2, 2014 and the Postmarket guidance was issued on December 28, 2016. Both documents emphasize the need for manufacturers to take a risk-based approach to:
I.The Cybersecurity of the medical devices themselves.
II.The network(s) they may be designed to integrate with.
III.The impact on other devices which they may interface with.
IV.The intended use environment the device will operate in.

Cybersecurity is a dynamic topic that continues to evolve as more medical devices are connected to Electronic Medical Record (EMR) systems as part of their product requirements. 

Methodologies that will be discussed for meeting the requirements of the guidance documents will include Common Vulnerability Scoring System (CVSS), a risk management process similar to ANSI/AAMI/ISO 14971, along with customized approaches previously used by the presenters.
In addition, the presenters of this program will discuss their experience with Cybersecurity for medical devices and will demonstrate various approaches     that can be taken to address the FDA guidance documents.

This presentation will provide an overview of the FDA guidance documents along with three use cases that will give the audience an idea of the approaches taken to fulfill the objectives of those documents.  Followed by Q&A

Key Takeaways:
• Identify the information that the FDA will be looking for from the medical device manufacturers.
• Gain a sense of the possible approaches that may fit with a given medical device.
• Understand the relationship of medical device security to patient safety.
• Establish contact points for further information: documentation/standards, involvement in user groups (ISAOs), mailing lists, and websites.

 

Course Fee: $45 (non refundable but transferable within company)

Program partner:
Design Solutions, Inc.

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