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Software Bill of Materials for Medical Devices

The FDA is looking to make them mandatory

Wade Schroeder
Tue, 04/05/2022 - 12:02
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On May 12, 2021, President Biden signed the Executive Order on Improving the Nation’s Cybersecurity. Among other items in the order was a requirement that every vendor that supplies the federal government with software must provide a software bill of materials (SBOM) with their product.

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Given that the federal government spends nearly $100 billion a year on IT services, the executive order has put a spotlight on the concept of an SBOM and cybersecurity in general.

Nowhere are these issues more pressing than in the medical device industry, where lives depend on the development of safe and secure software. So today, let’s take a look at the SBOM and the role it plays in medical device manufacturing and cybersecurity.

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Comments

Submitted by kanhasoft on Thu, 02/13/2025 - 04:34

custom software development

This is a very insightful post on the importance of a Software Bill of Materials for Medical Devices. Ensuring transparency in the software components used is crucial for compliance and patient safety. I've seen firsthand how effective custom software development can streamline the management of software supply chains in highly regulated industries like healthcare. Thanks for sharing such valuable information!

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