Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia

Automating Quality

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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices.

"Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise.

Key Takeaways

01:10 Introducing today’s guest: Joseph Silvia

02:35 What is an SBOM?

04:24 What is the history of SBOM?

05:50 Now, the government is getting involved and SBOM is picking up steam.

06;35 What is the FDA’s expectation on this topic for the medical devices industry?

09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it?

11:38 Who is responsible for SBOM within organizations?

14:37 Where can listeners learn more about this topic?

Reach Joseph at jsilvia@medwarecyber.com

59 episoade

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