Blue Goat CyberSMMedical Device Cybersecurity
    K
    Network & Infrastructure Testing

    SOC 2 Penetration Testing

    SOC 2 penetration testing mapped to CC4.1, CC7.1, and CC7.2. NIST SP 800-115 and OWASP methodology, CVSS-scored findings, retest letter for the CPA, and one report that also serves HIPAA, HITRUST, and FDA workstreams.

    250+ FDA submissions. Zero rejections.

    • Senior team
    • Fixed-fee
    • Reviewer-ready
    • Re-test included
    • Free 30-min call
    • No obligation
    • Senior expert, not a sales rep
    • Fixed-fee quote in 24 hours
    • NDA available on request

    Trusted by leading MedTech companies

    Intuitive Surgical logo, Blue Goat Cyber client
    bioMérieux logo, Blue Goat Cyber client
    Inogen logo, Blue Goat Cyber client
    Natera logo, Blue Goat Cyber client
    Velico Medical logo, Blue Goat Cyber client
    Medivis logo, Blue Goat Cyber client
    Spiro Robotics logo, Blue Goat Cyber client
    Nova Biomedical logo, Blue Goat Cyber client
    VitalConnect logo, Blue Goat Cyber client
    Intuitive Surgical logo, Blue Goat Cyber client
    bioMérieux logo, Blue Goat Cyber client
    Inogen logo, Blue Goat Cyber client
    Natera logo, Blue Goat Cyber client
    Velico Medical logo, Blue Goat Cyber client
    Medivis logo, Blue Goat Cyber client
    Spiro Robotics logo, Blue Goat Cyber client
    Nova Biomedical logo, Blue Goat Cyber client
    VitalConnect logo, Blue Goat Cyber client
    Trevor Slattery, COO

    Reviewed by Trevor Slattery · COO

    Last reviewed May 2026

    What's included

    Reviewer-ready deliverables in one engagement

    Every soc 2 penetration testing engagement ships with the artifacts FDA reviewers expect to see - traceable, complete, and aligned with current guidance.

    • Scope aligned to your SOC 2 system boundary
    • Test cases mapped to AICPA Trust Services Criteria
    • External network, web app, API, and cloud configuration
    • CVSS-scored findings with reproduction steps
    • Free retest of criticals and highs within 90 days
    • Audit-ready report and attestation letter for your CPA
    Relevant standards

    Standards this service maps to

    Every soc 2 penetration testing engagement produces evidence aligned to the regulatory and consensus standards FDA reviewers and notified bodies expect to see - traceable, complete, and ready to drop into your ISO 13485 quality system.

    Featured site-wide
    NIST SP 800-115

    Technical Guide to Information Security Testing

    Reference methodology for planning, executing, and reporting security testing.

    NIST CSF 2.0

    Cybersecurity Framework

    Govern, Identify, Protect, Detect, Respond, Recover - the lingua franca for cybersecurity program maturity.

    IEC 62443-4-1

    Secure Product Development Lifecycle

    Industrial-strength secure-development-lifecycle requirements applied to connected medical devices.

    Related services mapped to the same standards

    FAQ

    SOC 2 Penetration Testing FAQs

    In their words

    Backed by MedTech leaders.

    HT
    "Blue Goat Cyber's depth of expertise was impressive. We had no in-house cybersecurity experience, and their team guided us through every step of the FDA process. The penetration testing and SBOM testing were thorough and gave us complete confidence."
    Hank Tucker
    CEO · MedTech Manufacturer
    Ready to start SOC 2 Penetration Testing?

    SOC 2 Penetration Testing - scoped, fixed-fee, FDA-ready.

    SOC 2 penetration testing mapped to CC4.1, CC7.1, and CC7.2. NIST SP 800-115 and OWASP methodology, CVSS-scored findings, retest letter for the CPA, and one report that also serves HIPAA, HITRUST, and FDA workstreams.