What does FDA premarket cybersecurity guidance actually require?

For applicable devices, FDA expects a cybersecurity management plan, SBOM, vulnerability handling process, and documentation of security controls as part of the submission — this became a statutory requirement under Section 524B for cyber devices. We help build the documentation and technical evidence, though the submission review itself is FDA's call.

How do you patch validated systems without breaking validation?

Through change-controlled, risk-based patching that documents the impact assessment before and after each change, consistent with your existing validation/quality process rather than a blanket patch-everything approach.

What is an SBOM and do we need one?

A Software Bill of Materials lists the software components in a device, which FDA increasingly expects for premarket submissions and post-market vulnerability monitoring on connected or software-containing devices. We generate and maintain SBOMs and track associated CVEs over time.

Does EU MDR require the same cybersecurity documentation as FDA?

EU MDR has its own cybersecurity expectations under the essential requirements and MDCG guidance, which overlap with but aren't identical to FDA's approach. We map controls to both where a device is sold in both markets.

How much does a cybersecurity program cost for a device manufacturer?

Costs vary significantly by company size and number of device lines; early-stage manufacturers preparing a first submission typically spend less than public manufacturers maintaining post-market monitoring across an existing device portfolio.

Can you work with our existing quality/regulatory affairs team?

Yes — we typically integrate with existing QA/RA processes rather than replacing them, since cybersecurity documentation needs to align with your existing ISO 13485 quality system.

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.

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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.

Answers

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Automotive Suppliers

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Behavioral Health

HIPAA + 42 CFR Part 2 for behavioral health providers.

Defense & DoD Suppliers

CMMC 2.0 & NIST 800-171 for the defense industrial base.

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