Medical Device Manufacturing

    FDA-Grade Cybersecurity. Validated Without Breaking Validation.

    FDA pre-market and post-market cybersecurity is no longer optional, and EU MDR is right behind it. We secure device makers without disrupting validated systems, design history files, or your next submission.

    We secureFDA Cybersecurity21 CFR Part 820ISO 13485ISO 14971EU MDRSBOM / SPDX

    Where Device Makers Get Caught

    FDA pre-market and post-market cybersecurity guidance now have teeth
    21 CFR Part 820 / ISO 13485 quality records can't be reconstructed after a breach
    Connected and SaMD devices need an SBOM and a documented vuln-management process
    EU MDR and FDA expect documented cybersecurity throughout the device lifecycle
    ERP, PLM, MES, and validated systems all live on a flat shop floor network
    Your IP — design history files, source code, firmware — is a nation-state target
    The Honest Comparison

    Generic MSP vs. TRNSFRM

    Capability
    Generic MedDevice MSP
    TRNSFRM
    FDA cybersecurity submissions
    Boilerplate
    Tailored to device, with SBOM + evidence
    SBOM management
    Doesn't exist
    Generated, tracked, post-market updated
    Validated system patching
    Break-fix only
    Risk-based, change-controlled, documented
    Design history protection
    Open shares
    Encrypted, access-logged, DLP-monitored
    OT / shop floor segmentation
    Flat network
    Segmented, monitored, IDS in place
    MFA + identity
    Optional
    Enforced on email, ERP, PLM, remote
    Incident response
    Improvise
    Documented for FDA + EU MDR timelines
    Audit & notified-body evidence
    Scramble
    Always-on evidence library
    What We Deliver

    IT & Security for Medical Device Makers

    FDA + 21 CFR 820 + ISO 13485 Program

    Cybersecurity controls and evidence aligned to QSR, ISO 13485, and FDA pre/post-market guidance.

    Validated System Protection

    Hardening and change-control for ERP, MES, PLM, and validated GxP systems without breaking validation.

    Manufacturer-Aware Managed IT

    Help desk, patching, and OT/IT segmentation tuned for regulated manufacturing environments.

    EDR + SOC for IP Protection

    24/7 monitoring tuned for IP-theft and ransomware against design and manufacturing systems.

    SBOM & Vulnerability Program

    Software bill of materials, CVE tracking, and post-market vulnerability response for connected devices.

    Fractional CISO for MedDevice

    Strategic security leadership for early-stage device makers through public manufacturers.

    Ready for Cybersecurity That Survives FDA Review?

    Book a free 30-minute risk call. We'll review your FDA, ISO 13485, and SBOM posture and show you where you're exposed.

    Explore more for device manufacturers

    HIPAA Framework

    When you handle patient data

    NIST CSF

    Cybersecurity framework

    Manufacturing IT

    Parent industry overview

    Healthcare IT

    Clinical IT overview

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