Security by design is crucial in MedTech. It means that cybersecurity must be built into the design from the start. It can’t be an afterthought.
Security by design principles requires a thorough understanding of cybersecurity vulnerabilities associated with the device or platform. You can use several frameworks, such as the NIST Cybersecurity Framework, the Center for Internet Security’s Critical Controls (CIS), and ISO/IEC 27001 and 27002. Organizations can use these as a starting point, customizing, as necessary.
Security by design doesn’t just support cybersecurity. It also provides support for the commercialization of the product. It helps establish risk management plans, the application of standards, penetration testing, monitoring, and more.
To develop the “right” security by design, you’ll also need to consider other factors like UX (user experience), social engineering and phishing threats, touchpoints, and product lifecycle stakeholders.
A complete medical device cybersecurity assessment provides you with an unbiased evaluation of what vulnerabilities remain. We recommend two Assessment Evolutions, which is a test/retest model. After the first test, there’s the opportunity for remediation. The second evolution tests to ensure that remediation addressed the concern.
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