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David Audrain's avatar

Very good article.

Note that this looks like what the FDA requires from medical device manufacturer: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

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Jon Oster's avatar

Really nice overview as always, Burkhard! I think that threat modeling and risk assessment are quite possibly the _most_ important elements of the CRA. How you define your threat model determines how you assess cybersecurity risks, and it's your assessment of cybersecurity risks that determines what controls or mitigations you need to apply. So a poorly done threat model or risk assessment can add serious cost and complexity to the final built product--we all know that bolting on security features after the fact is 10x as expensive and 1/10th as effective as building security in from the start.

One thing I'll add on that topic is that cybersecurity risk management isn't so different from risk management in other domains, at least at a high level. The four basic tools are the same: Avoid, Reduce, Transfer, Accept. There are really just two main differences: first, we usually refer to risk reduction strategies as "mitigations" or "controls", and the line between avoiding risk and reducing risk is slightly fuzzier. And second, regulations like the CRA make it much more difficult to just accept cybersecurity risks, and basically impossible to transfer them to 3rd parties.

I'd also like to mention something on the topic of vulnerabilities. Although you're of course right in your description of generic, product-wide vulnerabilities, it's worth giving special attention to CVE management, i.e. the process and strategy for dealing with documented vulnerabilities in the open-source dependencies of the product. A risk that applies to every product is "an exploitable vulnerability is discovered in one of my software dependencies"--and the only effective mitigation for that risk is to make sure an accurate, actionable SBOM for the product exists, and regularly scan it for exposure to CVEs.

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