Cybersecurity for Medical Devices

Get documentation to meet FDA expectations and move forward with confidence.

Cybersecurity gaps can stop your submission in its tracks

Building a medical device today means more than proving it works—it means proving it’s secure.
If your device connects to software, networks, or external systems, the FDA expects clear, structured cybersecurity documentation, testing, and risk management as part of every submission.
But many teams run into the same challenges.

Whether you’re developing a new product or updating a legacy device, cybersecurity issues can delay approval, force rework, or require you to start over.

You’re not sure what cybersecurity documentation is required.
Your design files don’t account for modern cybersecurity expectations.
You’re approaching submission and realizing something is missing.
You received FDA feedback (AINN) and need to fix gaps—fast.

Cybersecurity Built Into Your Development Process

RCA helps you get your cybersecurity right the first time. We integrate cybersecurity directly into your product development lifecycle so everything aligns with FDA expectations from the start.

Exploitability-Based Risk Management

Reduce the risk of delays or rejected submissions by addressing real, exploitable threats the way the FDA expects.

FDA-Ready Documentation

Submit with confidence knowing your cybersecurity documentation is clear, complete, and easy for reviewers to evaluate.

End-to-End Support

We’ll help you integrate cybersecurity at any stage, whether you’re early in development, well along in the process, or are updating a legacy device.

Clarity at Every Step

Move forward with a clearly defined plan, with full visibility into next steps and priorities, while eliminating uncertainty and inefficiencies.

Our Cybersecurity Services

Penetration Testing & Threat Modeling

We provide comprehensive, rigorous penetration testing and threat modeling that help: 

  • Validate that your controls perform as intended
  • Identify, contextualize, and assess your software’s flaws 
  • Highlight where flaws can impact the safety and effectiveness of your device 

Our medical device penetration testing includes: 

  • Discovery & Reconnaissance
  • Vulnerability Analysis
  • Authentication Testing
  • Dynamic Analysis Testing
  • Static Analysis Testing
  • Firmware & Software Reverse Engineering
  • Cloud, Web, & API Testing
  • Mobile Application Testing
  • Fuzz Testing
  • Vulnerability Chaining
  • Exploitation Testing
  • Kiosk & User Interface Security Testing
  • Enclosure Tamper Testing
  • Hardware Layer Evaluation
Cybersecurity Risk Management

We develop the foundational cybersecurity risk management plan required for FDA submission.

  • Built using an exploitability-based framework, rather than traditional safety risk
  • Defines how risks are identified, evaluated, and controlled
  • Establishes the structure for all downstream documentation and testing
Regulatory Documentation Development

We create and align the full set of cybersecurity documents required for submission.

Core Documents Include:

  • Design Requirements
  • Threat Modeling
  • Software Requirements Specification (SRS)

Final Submission Document:

  • Cybersecurity Risk Analysis Report
    • Consolidates all risk, testing, and validation data
    • Written in clear, FDA-ready language for efficient review
SBOM Management & Analysis

We support compliance with FDA requirements for Software Bill of Materials (SBOM): Our services help your team: 

  • Review and analyze machine-readable SBOMs
  • Identify vulnerabilities across all software components
  • Prioritize remediation using structured analysis

Includes:

  • VEX Analysis – Determines which vulnerabilities are relevant to your device

KEV Analysis – Identifies known exploitable vulnerabilities that require action

Vendor Oversight & Report Remediation

We review, refine, and, when needed, rewrite third-party cybersecurity reports to help: 

  • Align external testing reports with FDA expectations
  • Ensure documentation includes the specific language reviewers look for
  • Deliver reports that are clear, searchable, and defensible
FDA Response Support (AINN)

We help you respond to FDA cybersecurity feedback with speed and precision, allowing you to: 

  • Address each requirement clearly and completely
  • Align documentation, testing, and risk analysis
  • Meet deadlines and avoid resubmission

How RCA Can Help with the Development Process

Medical device development requires a coordinated, multi-phase approach. RCA is here to help you at any stage of development, customizing a process that supports progress while identifying and managing risk every step of the way.

Concept & FeasibilityDefines the intended use and identifies early risks. RCA clarifies regulatory classification and establishes initial requirements to prevent missteps.
Design Inputs & User NeedsEstablishes what the device must do through measurable requirements. RCA develops clear, traceable inputs that align teams and minimize downstream issues.
Design & DevelopmentCovers engineering, prototyping, and documentation of design decisions. RCA integrates ongoing risk management into design decisions, building a complete, FDA-aligned development file.
Verification & ValidationConfirms the device meets requirements through testing and usability validation. RCA ensures risk controls are properly tested, documented, and ready for submission.
Transfer to ManufacturingPrepares the product for scalable, repeatable production. RCA carries risk considerations into manufacturing, ensuring processes and specifications deliver consistent performance.
Regulatory Submission & ClearanceSupports FDA submission with required documentation and evidence. RCA aligns risk management documentation with regulatory expectations, ensuring all materials are complete, aligned, and defensible.
Post-Market ComplianceMaintains ongoing quality and regulatory readiness. RCA supports continuous compliance through updates, risk management, and audit preparedness.

Connect with RCA Today

Contact us to learn more about our regulatory compliance experts and how they can help

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