INTRODUCTION
As Sweden accelerates its digital-health transformation, medical devices are becoming smarter, more interconnected, and deeply integrated into clinical workflows. Hospitals, diagnostic centers, and telehealth platforms now depend heavily on connected medical technologies—from infusion pumps and imaging systems to mobile health apps and remote monitoring solutions.
However, this connectivity introduces new cybersecurity vulnerabilities. The U.S. FDA has tightened regulations by mandating strong cybersecurity controls for all devices undergoing 510(k) premarket submissions. For Swedish medical device manufacturers, software developers, and healthcare innovators looking to access the U.S. market, cybersecurity compliance is now non-negotiable.
This is where Cyberintelsys, backed by CREST-certified cybersecurity professionals, helps organisations navigate FDA expectations, manage cybersecurity risks, and achieve seamless 510(k) submission readiness.
Cybersecurity is Now a Core FDA Requirement for 510(k)
Since the introduction of the FDA’s updated guidance—especially the 2023–2024 revisions—cybersecurity is considered a mandatory safety and effectiveness factor for all cyber-enabled medical devices.
Key FDA expectations include:
Secure product design
You must demonstrate secure-by-design practices, including:
Threat modeling
Secure architecture
Data protection controls
Hardening procedures
Comprehensive SBOM (Software Bill of Materials)
Every component, library, open-source dependency, and version must be clearly listed.
Vulnerability management plan
Manufacturers must show how they identify, rate, patch, and disclose vulnerabilities.
Postmarket cybersecurity processes
FDA now expects continuous monitoring, coordinated disclosure, and patch timelines.
Evidence-driven testing
Your submission must include cybersecurity test results:
Vulnerability assessment (VA)
Penetration testing (PT)
Source-code security analysis
Interface and API testing
Wireless security validation
Cyberintelsys ensures all the above elements are adequately documented and ready for submission.
Why Swedish Manufacturers Face New FDA Cybersecurity Challenges
Sweden’s health device ecosystem is advanced, but FDA 510(k) cybersecurity demands are very specific. Common challenges include:
Lack of U.S.-style documentation
Incomplete threat modeling
Limited SBOM maturity
Insufficient penetration testing evidence
Missing post-market cybersecurity strategy
Gaps in risk control traceability (FDA, AAMI, ISO alignment)
Cyberintelsys bridges these gaps by combining FDA regulatory expertise, CREST security testing, and medical device cybersecurity frameworks like:
AAMI TIR57
AAMI TIR97
IEC 81001-5-1
ISO 14971 risk management
IEC 62304 secure software lifecycle
Cyberintelsys: Your Partner for 510(k) Cybersecurity Across Sweden
Cyberintelsys supports Swedish manufacturers with end-to-end cybersecurity compliance to accelerate 510(k) submissions. Their team includes CREST-certified penetration testers, medical device cybersecurity engineers, and regulatory strategists.
Our Core Services
FDA 510(k) Cybersecurity Gap Assessment
A deep-dive evaluation of your:
Design controls
Documentation
Risk files
Security testing evidence
Patch management
Vulnerability disclosure plan
SBOM maturity
Outcome → A remediation roadmap aligned with FDA expectations.
Threat Modeling & Secure Architecture Review
Cyberintelsys performs:
STRIDE-based threat modeling
Data-flow mapping
Attack-surface identification
Security-by-design alignment for 510(k)
This ensures that device functionality, data transmission, APIs, and wireless modules meet the security benchmarks FDA expects.
CREST-Backed VA/PT for 510(k) Submission
FDA strongly prefers testing conducted by recognised cybersecurity bodies.
Cyberintelsys leverages CREST-certified testers to deliver:
Network and interface penetration testing
Cloud and backend security assessments
Firmware and embedded device testing
Mobile app and companion software testing
API and interoperability security testing
Wireless & Bluetooth security analysis
Full testing reports are tailored for 510(k) submission format.
SBOM Development & Vulnerability Traceability
Cyberintelsys creates a complete Software Bill of Materials and aligns it with:
FDA requirements
NTIA SBOM standards
IEC 81001-5-1 practices
Each component includes known vulnerabilities mapped to CVE, CVSS scoring, and mitigation steps.
510(k) Cybersecurity Documentation Package
Cyberintelsys prepares all mandatory documents:
System security architecture
Cybersecurity risk assessment
Mitigation and control matrix
Secure development lifecycle (SDLC) evidence
Penetration testing report
Vulnerability management plan
Patching policy
Cybersecurity labeling content for users
All content is structured exactly as FDA reviewers prefer.
Postmarket Cybersecurity Strategy for FDA Compliance
The FDA now requires manufacturers to show:
Monitoring strategies
Coordinated vulnerability disclosure
Patch deployment timelines
Security update process
Cyberintelsys builds a complete postmarket cybersecurity framework customised for your device.
Why CREST Certification Matters for FDA 510(k)
FDA doesn’t officially “approve” specific certification bodies, but in practice, submissions backed by industry-recognized certifications carry more trust.
CREST certification ensures:
Penetration testing meets global standard
Testers follow ethical and technical competency frameworks
Evidence is robust and repeatable
Reports withstand regulatory scrutiny
For Swedish manufacturers, CREST-backed cybersecurity testing reduces:
Risk of FDA rejection
Supplemental information requests
Documentation delays
Re-testing cycles
Sweden’s Medical Device Landscape: Why Strong Cybersecurity Is Essential
Modern Swedish medical technology companies are innovating rapidly in:
Remote heart monitoring
AI-driven imaging analytics
Mobile diagnostic platforms
IoMT devices
Surgical robotics
Smart home-care systems
But these innovations increase attack exposure. Research shows cyberattacks targeting medical devices are rising across Europe, especially ransomware attacks on hospitals.
Strong cybersecurity ensures:
Patient safety
Device reliability
Regulatory approval
Market trust
Reduced liability
Cyberintelsys helps Swedish innovators build world-class secure systems ready for the U.S. market.
Step-by-Step Process: How We Prepare You for FDA 510(k) Submission
Step 1 – Cybersecurity Gap Analysis
We evaluate your device against FDA guidance, AAMI, MITRE, and IEC standards.
Step 2 – Threat Modeling & Secure Architecture Fixes
We refine your risk controls and data-flow security.
Step 3 – CREST VA/PT & Security Validation
Testing is performed, documented, and aligned with 510(k) evidence requirements.
Step 4 – SBOM + Vulnerability Mapping
We compile and validate the SBOM.
Step 5 – Documentation Package Creation
Cybersecurity reports, risk matrices, and labeling documents are prepared.
Step 6 – Final 510(k) Review Support
We ensure the submission is complete and FDA-ready.
Why Choose Cyberintelsys for FDA 510(k) Cybersecurity in Sweden?
Experience supporting FDA submissions
CREST-certified penetration testing team
Dedicated medical device cybersecurity engineers
Expertise with IEC 81001-5-1, 62304, and 14971
Faster remediation cycles
Tailored documentation aligned with FDA expectations
End-to-end compliance support
Cyberintelsys delivers a complete, submission-ready cybersecurity package designed to improve approval chances and reduce time-to-market.
Conclusion: Strengthen Your FDA 510(k) Strategy with World-Class Cybersecurity
For Swedish health-tech innovators, U.S. FDA 510(k) clearance is a gateway to the world’s largest medical device market. But without strong cybersecurity, even well-designed products can face delays or rejection.
With Cyberintelsys and CREST-certified testing, manufacturers can:
Build secure, trusted medical devices
Eliminate compliance gaps
Provide defensible documentation
Accelerate FDA approval
Improve patient safety and product resilience
Strong cybersecurity is not just a requirement—it’s a competitive advantage.
