Live Webinar
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Cybersecurity in Medical Devices:
Practical Advice for FDA’s 510(k) Requirements
Threat Modeling and Risk Assessment: A Step-by-Step Example
September 26, 2024 | 1 pm EDT
Threat modeling and performing a risk assessment are required by the FDA as part of a 510(k) pre-market submission and will tell you what cybersecurity is needed to make sure your medical device is secure.
Using an example based on a medical device from the MITRE and MDIC’s Playbook for Threat Modeling Medical Devices, webinar presenters will go step-by-step through a threat model and risk assessment for a number of attack paths to clearly show how it is done.
These steps include:
- Identification of assets
- Identification of threats based on STRIDE
- Rating the impact of threats
- Defining attack paths
- Rating difficulty of attack paths
- Decision to mitigate or not based on level of risk
- Rating of risk after security controls are in place
You will also learn how to migrate your findings into an actionable cyber controls design to address your risks.
By the end of the webinar you will have a very good idea of how to develop a cybersecurity threat model and to perform risk analysis. All registrants will receive the threat modeling/risk assessment spreadsheet shown, which can be used as part of an actual submission to the FDA.
To register, please submit the form:
About The Presenters
Milton Yarberry
ICS
Milton is the Director of Medical Programs for ICS. He is a certified PMP and Scrum Master with a background in software architecture, medical device product development and program management. He has 20 years in product development with 10 years in software consulting and 15 years working with Class II and Class III medical device manufacturers.
Colin Duggan
BG Networks
Colin is the founder and CEO of BG Networks. Before founding BG Networks in 2020, Colin worked at Analog Devices (ADI) for 29 years in various engineering, management, and marketing leadership roles managing teams located in U.S., China, Europe, and India. Colin’s experience includes work in automotive, consumer, industrial, and aerospace & defense markets.
David Sequino
ISS
With more than two decades experience, David is delivering next generation end-to-end embedded security to all safety critical IOT devices. As ISS Founder and CEO, David and team are securing and managing over 2 billion IOT devices and counting. David holds a bachelor of science degree in electrical engineering from Northeastern University and attended MIT’s Sloan School of Management’s Executive Leadership program.