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    Secure-by-Design (Devices)

    Engineering principle of building security in from initial architecture rather than bolting it on.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Secure-by-design products eliminate entire classes of vulnerabilities through memory-safe languages, least-privilege design, default deny, and threat modeling at architecture phase. CISA promotes secure-by-design as a manufacturer responsibility.

    What this means in practice

    Increasingly an expectation in FDA premarket cyber feedback and a procurement criterion for hospital IT.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    CISA·1IMDRF·1MDCG·1
    1. 1
      CISA Secure by Design
      Verified
      CISAcisa.gov
    2. 2
      IMDRF - Software as a Medical Device
      Verified
      IMDRFimdrf.org
    3. 3
      MDCG Software Guidance
      Verified
      MDCGhealth.ec.europa.eu

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