CyberMed
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Medical device cybersecurity consulting for the section of your submission that has to clear.

CyberMed provides medical device cybersecurity services for FDA submissions: architecture, threat modeling, documentation, testing, and post-market plans. Maybe the submission is months out. Maybe FDA already sent a letter. Maybe the device is on the market and nobody owns post-market security. Pick the piece you need or take the whole package.

Medical device cybersecurity consulting covers the work a manufacturer needs to show FDA that a connected device is secure by design: security architecture, threat modeling, risk assessment, SBOM, verification and penetration testing, labeling, and postmarket planning. Section 524B of the FD&C Act requires this evidence for cyber devices. CyberMed delivers each piece or the whole package, written for the reviewer.

By Jose Bohorquez, PhD, President · Updated

Book a callCheck your cyber readiness
Class II & III devicesSaMD & cloud platformsConnected hardwareIEC 62304 & ISO 13485

30-Day CyberSprint

The complete package. Every cybersecurity document and test report FDA expects, delivered in two phases over 30 days at a fixed price. If FDA questions anything we prepared, we answer it at no extra cost.

See the full CyberSprint offer

What You Get

Architecture Phase

  • Security architecture views
  • Threat model
  • Cybersecurity risk assessment
  • Cybersecurity controls specification
  • Safety and security vulnerability assessment
  • Cybersecurity management plan
  • Cybersecurity test plan

Implementation Phase

  • Penetration and fuzz testing
  • SBOM analysis (machine & human-readable)
  • Software level of support
  • Unresolved anomalies assessment
  • Cybersecurity testing report
  • Cybersecurity metrics
  • Summary report and eSTAR submission checklist

Additional Support

  • Independent third-party validation with Letter of Assessment
  • Post-submission support for FDA questions and documentation updates

Ideal For

  • Pre-market devices requiring complete cybersecurity documentation
  • Teams needing both architecture guidance and independent testing
  • Organizations preparing 510(k) or PMA submissions with embedded or connected devices

Independent Cybersecurity Testing

Obtain the third-party security validation FDA requires, backed by industry-standard methodologies and medical device expertise.

See the testing page

What You Get

Penetration Testing

  • OWASP-aligned web/mobile/API security assessment
  • Authentication and authorization validation
  • Encryption implementation verification
  • Access control testing across privilege levels
  • Input validation and business logic testing

Fuzz Testing

  • Medical data interface testing (HL7, FHIR, DICOM)
  • Protocol fuzzing for device communications
  • File format validation
  • Systematic input testing for patient safety-critical functions

Embedded Testing (when applicable)

  • Firmware analysis and reverse engineering
  • Wireless protocol security (Bluetooth, Wi-Fi, Zigbee, cellular)
  • Hardware security assessment
  • JTAG/debug interface testing

Documentation & Support

  • Comprehensive technical report with CVSS v4.0 risk ratings
  • FDA submission package with Letter of Assessment
  • ANSI/AAMI SW96 alignment documentation
  • Discounted retesting after remediation

Ideal For

  • Teams with existing security architecture needing independent validation
  • Organizations requiring third-party testing evidence for regulatory submissions
  • Companies seeking objective vulnerability assessment before market release

Cybersecurity & Software Gap Analysis

Understand exactly where your documentation stands and what's needed to meet FDA requirements before you invest in a full remediation program.

What You Get

Software DHF Evaluation

  • Software description assessment
  • Risk management file review
  • Software requirements specification (SRS) analysis
  • Architecture design evaluation
  • Software design specification (SDS) review
  • Development and maintenance practices assessment
  • V&V documentation review
  • Version history and unresolved anomalies evaluation

Cybersecurity DHF Evaluation

  • Security risk management report
  • Threat model assessment
  • Cybersecurity risk assessment review
  • SBOM and software level of support analysis
  • Vulnerability assessment evaluation
  • Cybersecurity controls review
  • Security architecture views
  • Testing documentation, management plan, and labeling assessment

Gap Analysis Report

  • Detailed report highlighting missing information and insufficient detail
  • Prioritized remediation roadmap with actionable next steps
  • Clear assessment of submission readiness

Ideal For

  • Pre-submission readiness checks
  • Due diligence assessments for investors or acquirers
  • Teams inheriting legacy projects with uncertain documentation status
  • Organizations preparing for design reviews or quality audits

Software DHF & Quality System Setup

Build a compliant software quality management system from the ground up with SOPs, training, and complete DHF documentation.

See the Software DHF program

What You Get

Quality System Foundation

  • 6 software SOPs covering QMS validation, development, maintenance, problem resolution, configuration management, and test fixture validation
  • Two comprehensive training sessions for your software development staff
  • FDA/IEC 62304 requirements implementation guidance

Architecture Phase Documents

  • Software development plan (SDP)
  • Software verification plan (SVP)
  • Software requirements specification (SRS)
  • System and software architecture design (SAD) charts
  • Software risk analysis table (SRAT)

Development & Test Phase Documents

  • Build and deploy procedures (B&DP)
  • Software verification test protocol (SVTP)
  • Software verification test report (SVTR) template
  • Software traceability matrix (STM)
  • Software/firmware description
  • Version history and unresolved anomalies templates

Ideal For

  • Teams establishing software quality systems for the first time
  • Organizations preparing their first 510(k) submission
  • Companies transitioning from informal to regulated software development
  • Growing startups building FDA-ready development infrastructure
Featured Insights

Go deeper on FDA cybersecurity expectations.

These guides show the frameworks and evidence we lean on when preparing submissions and defending them during review.

Engagement Models

Flexible Engagement Models Aligned to Your Development Stage

We structure our work around your delivery milestones and organizational needs, ensuring cybersecurity supports innovation instead of slowing it down.

Discovery & Planning

Begin with a gap analysis to understand your current state, then design a tailored remediation program that addresses your highest-priority needs first.

Sprint-Based Delivery

Intensive 2-4 week cycles focused on specific deliverables. Ideal for teams approaching submission deadlines or investment milestones.

Retained Partnership

Ongoing architecture reviews, documentation maintenance, and regulatory readiness support for scaling teams managing multiple products or continuous development.

Project-Based Packages

Fixed-scope engagements delivering complete cybersecurity programs, independent testing, or DHF documentation packages with clear deliverables and acceptance criteria.

Book a callCheck your cyber readiness

Want the fixed-scope version? See the 30-day CyberSprint. Need only the documents? See cybersecurity documentation. Prefer email? Send a note.