Description

“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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