Overview
Medical device manufacturers operating in or exporting to the United States must demonstrate strong cybersecurity readiness as part of FDA 510(k) premarket submissions. With the rapid adoption of connected medical devices, Software as a Medical Device (SaMD), cloud platforms, and Internet of Medical Things (IoMT), cybersecurity risks directly impact patient safety, device effectiveness, and regulatory approval.
FDA 510(k) Cybersecurity Readiness & Risk Assessment focuses on identifying, analyzing, and mitigating cybersecurity risks before market entry. These activities help manufacturers meet FDA expectations for secure design, risk management, and post-market resilience.
Cyberintelsys is a CREST-accredited medical device cybersecurity company providing FDA 510(k) cybersecurity readiness and risk assessment services across the United States. Our services combine regulatory expertise with deep technical security testing to support successful FDA clearance.
Why FDA 510(k) Cybersecurity Readiness Is Critical in the United States?
Key drivers for cybersecurity readiness and risk assessment:
FDA regulatory expectations: Demonstrate compliance with FDA 510(k) cybersecurity guidance and premarket documentation requirements.
Patient safety assurance: Identify cybersecurity risks that could affect clinical performance or patient outcomes.
Risk-based decision making: Apply structured risk assessment aligned with medical device safety principles.
Reduced regulatory delays: Avoid FDA additional information (AI) requests related to cybersecurity gaps.
Engaging a CREST-accredited provider ensures assessments are credible, repeatable, and regulator-ready.
Cyberintelsys FDA 510(k) Cybersecurity Readiness & Risk Assessment Approach
1. Cybersecurity Scoping & Asset Discovery
Identification of device hardware, firmware, operating systems, and software components
Mapping of network interfaces, wireless protocols, APIs, and cloud connectivity
Review of companion mobile applications, clinical systems, and update mechanisms
Deliverables: Asset inventory, data flow diagrams, and cybersecurity scope definition.
2. Threat Modeling & Risk Identification
Threat modeling using STRIDE and MITRE ATT&CK for ICS
Identification of misuse cases and potential attack paths
Mapping threats to safety and clinical impact
Output: Threat model documentation and preliminary risk register.
3. Security Testing & Risk Assessment
Targeted vulnerability assessment across device, application, and network layers
Configuration and architecture review against secure-by-design principles
Risk scoring based on likelihood, exploitability, and patient safety impact
Deliverable: Cybersecurity risk assessment report aligned with FDA 510(k) expectations.
4. Risk Control & Mitigation Mapping
Mapping of identified risks to security controls and mitigations
Alignment with secure development lifecycle (SDLC) practices
Validation of compensating controls and residual risk
5. Reporting & FDA Documentation Support
Cybersecurity readiness reports suitable for inclusion in FDA 510(k) submissions
Risk traceability matrices linking threats, vulnerabilities, and controls
Clear remediation guidance aligned with FDA cybersecurity guidance
Standards & Framework Alignment
Our cybersecurity readiness and risk assessment services align with:
FDA 510(k) cybersecurity guidance
IEC 60601 Compliance Services for electrical medical device safety
IEC 81001-5-1 for health software cybersecurity
ISO 14971 medical device risk management
NIST cybersecurity framework
ISA/IEC 62443 for IoMT and industrial security
Benefits of FDA 510(k) Cybersecurity Readiness Services
1. FDA Submission Confidence
Well-structured cybersecurity evidence for FDA reviewers
Reduced risk of submission delays or rejection
2. Proactive Risk Reduction
Early identification of high-impact cybersecurity risks
Lower remediation costs before market launch
3. CREST-Accredited Expertise
Assessments performed by certified cybersecurity professionals
Globally recognised and trusted testing methodologies
4. Patient Safety & Trust
Stronger protection of connected medical devices
Increased confidence among healthcare providers and regulators
Medical Devices & Technologies Covered
Cyberintelsys supports FDA 510(k) cybersecurity readiness for:
Diagnostic and imaging medical devices
Therapeutic and life-sustaining devices
Patient monitoring and wearable devices
SaMD, cloud platforms, and medical APIs
Embedded systems and connected IoMT technologies
Why Choose Cyberintelsys in the United States?
CREST-accredited cybersecurity company trusted globally
Deep FDA 510(k) cybersecurity expertise for US market entry
Regulatory expertise spanning FDA 510(k), IEC 60601 Compliance Services & IEC 81001-5-1, ISO, and NIST frameworks
Audit-ready documentation tailored for FDA reviewers
US-focused delivery model supporting manufacturers nationwide
Conclusion
For medical device manufacturers in the United States, FDA 510(k) Cybersecurity Readiness & Risk Assessment is essential to demonstrate secure design, effective risk management, and regulatory compliance.
Cyberintelsys delivers CREST-accredited cybersecurity readiness and risk assessment services that help manufacturers:
Identify and manage cybersecurity risks proactively
Meet FDA 510(k) cybersecurity documentation requirements
Strengthen patient safety and device resilience
Achieve confidence in FDA premarket submissions
Partner with Cyberintelsys to ensure your medical devices are cybersecurity-ready, FDA-compliant, and prepared for successful entry into the United States market.