On-Demand Webinar
Cybersecurity in Medical Devices:
Practical Advice for FDA’s 510(k) Requirements
A Deep Dive into Secure Product Development Frameworks (SPDF)
“Cybersecurity threats have the potential to exploit one or more vulnerabilities that could lead to patient harm.”
This is the opening sentence to the initial SPDF section in the FDA’s pre-market cybersecurity guidance. In our second webinar in our series of Cybersecurity In Medical Devices: Practical Advice for FDA’s 510(k) Requirements, we tackle the question of what is a SPDF for medical device cybersecurity. As with all webinars in this series we look to provide actionable advice that clarifies implementation, and you can apply in your day-to-day tasks.
In order to implement an SPDF you'll need to know what it should include, whether there are existing process standards that can be leveraged, and what documentation elements the FDA is looking for.
In this webinar, we’ll cover:
- Introduction to SPDFs
- A foundation for a SPDF: an overview of IEC 81001-5-1 and AAMI SW96:2023
- SPDF documents the FDA has asked for
- An example of applying a SPDF
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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.