FDA Cybersecurity Requirements for Medical Devices
Map your documentation and testing strategy to every FDA expectation before you submit.
Read the article →Medical Device Cybersecurity Services Built for FDA Success
From initial gap analysis to complete cybersecurity programs, we deliver the documentation, testing, and architecture expertise that accelerates your path to market.
Class II & III devicesSaMD & cloud platformsConnected hardwareIEC 62304 & ISO 13485
Comprehensive Cybersecurity Program
Transform your device security posture with a complete, two-phase program that delivers every document FDA expects to see.
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.
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.
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.
Complete Guide to FDA Cybersecurity Risk Assessment
See how we quantify risk and evidence mitigations in submissions and post-market plans.
Read the article →Medical Device Secure Software Development Lifecycle
Adopt an SDLC blueprint that keeps engineers moving while satisfying regulators.
Read the article →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.