FDA Cybersecurity Requirements Are Complex and Constantly Evolving
You're building breakthrough medical device technology. But FDA cybersecurity requirements feel like a moving target.
IEC 62304. IEC 81001-5-1. Threat modeling. Software Bill of Materials. Residual risk assessment. Post-market surveillance plans. The guidance documents reference multiple standards that reference other standards.
You're facing critical challenges:
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Understanding which cybersecurity requirements apply to your specific device
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Creating documentation that FDA reviewers will actually accept
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Demonstrating comprehensive security without delaying your submission
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Building a cybersecurity framework during active development
The result: You're piecing together cybersecurity documentation from guidance documents, hoping it's sufficient. Your engineering team is brilliant at neuroscience but unsure about FDA cybersecurity expectations. You're worried about Information Requests that could delay approval by 6-12 months.
You don't need generic cybersecurity consulting. You need FDA regulatory expertise combined with medical device security knowledge.
You need experts who've successfully guided medical devices through FDA cybersecurity review.
We Navigate FDA Cybersecurity Requirements Daily
We understand the challenge of translating FDA cybersecurity guidance into actionable programs for medical device companies. We've seen brilliant engineering teams struggle with regulatory documentation not because they lack security, but because they don't speak FDA's language.
That's why we specialize in FDA cybersecurity compliance for medical devices.
Our Expertise
✓ FDA Leadership - Leading FDA cybersecurity work for implantable brain-computer interfaces
✓ IEC 81001-5-1 Specialists - Deep expertise in the security risk management standard FDA expects
✓ Standards Development - Contributing to IEEE/IEC standards that inform FDA guidance
✓ Successful Submissions - Companies we've supported achieved FDA approval with zero cybersecurity findings
✓ Medical Device Focus - We understand your device constraints, not just IT security
We don't just know cybersecurity. We know how FDA evaluates cybersecurity.
When You Need FDA Cybersecurity Compliance
At Multiple Stages Throughout Your Device Lifecycle
FDA cybersecurity isn't just for pre-market submission. It's an ongoing requirement from initial design through post-market surveillance.
Pre-Development Planning
18+ months to FDA
What You Need:
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Security requirements definition
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Cybersecurity framework selection
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Security risk management plan
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Integration with design controls
Why Now:
Establish cybersecurity foundation before development starts. Avoid costly redesigns when requirements are discovered late.
Our FDA Cybersecurity Services
Comprehensive Regulatory Support for Medical Devices
We offer a complete range of FDA cybersecurity compliance services, each designed to navigate the unique regulatory requirements of medical devices.
FDA Cybersecurity Gap Analysis
Comprehensive assessment of your current cybersecurity posture against FDA requirements to identify gaps and create remediation roadmap.
What We Assess:
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Regulatory Requirements
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Documentation Completeness
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Security Controls
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Development Process Integration
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Post-Market Readiness
The Nave Security Difference:
✓ FDA-Focused Assessment - We assess against what FDA reviewers actually look for, not generic checklists
✓ Medical Device Context - We understand device constraints and clinical workflow requirements
✓ Actionable Roadmap - Prioritized remediation plan with realistic timelines
✓ Standards Expertise - Deep knowledge of IEC 81001-5-1 and how FDA interprets it
✓ Submission Experience - We know which gaps will actually delay approval
How We Work
Your FDA Compliance Pathway
What Happens Without Proper FDA Cybersecurity Compliance
Every gap in FDA cybersecurity documentation puts your approval at risk
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FDA Delays & Additional Costs
6-12 month delays from inadequate cybersecurity documentation. Emergency consulting to address Information Requests. $2-5M in additional burn waiting for approval.
2
Submission Rejection
FDA refuses to file submission due to incomplete cybersecurity documentation. Major documentation rework required. Submission timeline reset to zero.
3
Post-Market Compliance Failures
No vulnerability monitoring process. FDA enforcement actions for post-market cybersecurity failures. Costly retrofits to deployed devices.
"Nave Security transformed our scattered security documentation into a comprehensive, FDA-ready package. They understood both the regulatory requirements and our BCI technology. The FDA reviewers specifically commented on the quality of our cybersecurity documentation. Worth every penny to avoid the nightmare of Information Requests."
VP of Regulatory Affairs, BCI Company
Download Our Free FDA Cybersecurity Documentation Checklist
Inside, you'll find:
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Why penetration testing alone won't satisfy FDA reviewers
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The documentation gaps that consistently delay pre-market submissions
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A practical framework to align your device with current FDA expectations
We created this checklist to help medical device teams understand what FDA reviewers actually look for, and what documentation many teams overlook until it's too late.