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    MedTech Cyber Tips
    The Ultimate Guide
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    MedTech Cyber Tips Editorial Team

    Medical Device Cybersecurity Editors

    Editorial standards, technical review, and regulatory alignment.

    Editorial background

    The MedTech Cyber Tips editorial team is a group of practitioners with hands-on experience across FDA premarket cybersecurity submissions, Secure Product Development Framework (SPDF) implementation, medical device threat modeling, and postmarket vulnerability management. Every article, checklist, and update on this site is reviewed for accuracy against the FDA's February 3, 2026 final premarket cybersecurity guidance, Section 524B of the FD&C Act, MDCG 2019-16 Rev.2, IEC 81001-5-1, ISO 14971, and the EU Cyber Resilience Act. The team also tracks 510(k) deficiency patterns and CVE trends affecting connected medical devices so guidance on the site stays current.

    Areas of expertise

    • Medical device cybersecurity
    • FDA Section 524B
    • FDA premarket cybersecurity guidance (Feb 3, 2026)
    • Secure Product Development Framework
    • SBOM and VEX
    • Medical device threat modeling
    • Postmarket vulnerability management
    • EU MDR cybersecurity (MDCG 2019-16 Rev.2)
    • EU Cyber Resilience Act
    • IEC 81001-5-1
    • ISO 14971 risk management

    Recent reviewed articles

    Topics reviewed