Overview
In the United States, medical device software is increasingly connected, cloud-enabled, and integrated with hospital IT networks. From Software as a Medical Device (SaMD) to embedded device software and remote monitoring platforms, cybersecurity has become a critical patient safety and regulatory requirement. Cyber threats targeting medical devices can lead to data breaches, device malfunction, patient harm, and regulatory action.
IEC 81001-5-1 provides internationally recognised guidance for cybersecurity risk management of health and medical device software throughout the product lifecycle. It complements U.S. regulatory expectations by emphasizing secure design, development, testing, deployment, and post-market maintenance.
Cyberintelsys, a CREST-accredited cybersecurity company, delivers cybersecurity readiness and risk assessment services aligned with IEC 81001-5-1 to support medical device software compliance across the United States.
Importance of Cybersecurity Readiness for Medical Device Software
Medical device software is a high-value target due to patient safety impact, sensitive health data, and strict regulatory oversight. Common cybersecurity risks include:
Insecure authentication and access control in device software and companion applications
Vulnerabilities in wireless, Bluetooth, and network communication protocols
Insecure APIs and cloud backends supporting connected devices
Weak encryption, key management, and firmware protection
Supply chain risks and vulnerable third-party components
Cybersecurity readiness and risk assessment are essential to:
Identify and mitigate cybersecurity risks throughout the device lifecycle
Align with IEC 81001-5-1 risk management expectations
Support U.S. FDA cybersecurity requirements and premarket submissions
Protect patient safety, device functionality, and data integrity
Demonstrate due diligence to regulators, healthcare providers, and partners
Cyberintelsys CREST-Accredited Risk Assessment Approach
Cyberintelsys follows a structured, risk-based methodology aligned with CREST standards and international compliance frameworks such as IEC 81001-5-1, IEC 60601, and IEC 62443.
1. Scope Definition & Asset Identification
Identify medical device software components including embedded firmware, companion mobile apps, web portals, APIs, and cloud services
Map device connectivity, data flows, trust boundaries, and safety-critical functions
Define controlled assessment boundaries to ensure patient safety and regulatory compliance
Deliverables: Scope document, software asset inventory, and risk assessment plan
2. Cybersecurity Risk Assessment
Identification of threats, vulnerabilities, and attack surfaces affecting device software
Threat modelling using STRIDE and MITRE ATT&CK for ICS
Assessment of security controls protecting device integrity, availability, and confidentiality
Evaluation of third-party libraries, operating systems, and supply chain components
Output: Risk register with likelihood, impact, and risk ratings mapped to patient safety
3. Vulnerability Assessment & Penetration Testing
Secure testing of medical device software, APIs, and supporting infrastructure
Simulation of real-world attack scenarios targeting device communication and control paths
Validation of encryption, authentication, firmware update mechanisms, and access controls
Deliverable: Technical findings report with proof-of-concept evidence and remediation guidance
4. Risk Prioritisation & Mitigation Planning
Prioritise risks based on exploitability, safety impact, and regulatory relevance
Develop remediation and risk treatment plans aligned with IEC 81001-5-1 principles
5. Compliance Reporting & Documentation
Audit-ready documentation supporting FDA 510(k) Cybersecurity Compliance
Clear traceability between risks, controls, and mitigation measures
6. Validation & Ongoing Readiness
Reassessment after remediation to confirm risk reduction
Support for post-market cybersecurity monitoring and continuous improvement
Methodology Overview
Architecture Review: Analyse medical device software architecture and connectivity
Threat Modelling: Identify attack paths using STRIDE and MITRE ATT&CK for ICS
Risk Evaluation: Assess likelihood and impact on safety, effectiveness, and compliance
Technical Testing: Validate security controls through targeted testing
Reporting: Deliver regulator-ready cybersecurity risk documentation
Benefits of Cyberintelsys Cybersecurity Services
Regulatory Alignment
Supports IEC 81001-5-1 cybersecurity risk management
Enables compliance with U.S. FDA premarket and postmarket cybersecurity expectations
Patient Safety & Device Integrity
Reduces cybersecurity risks that could affect device performance or patient outcomes
Protects sensitive patient and operational data
CREST-Accredited Expertise
Assessments performed by CREST-certified professionals
Ethical, standardised, and globally recognised testing practices
Operational & Market Readiness
Strengthens security posture prior to FDA submission or market launch
Builds trust with healthcare providers and regulatory authorities
Medical Device Software Supported
Cyberintelsys supports cybersecurity readiness for:
Software as a Medical Device (SaMD)
Embedded medical device firmware
Connected and wireless medical devices
Companion mobile and web applications
Cloud platforms supporting device data and analytics
Why Cyberintelsys in the United States?
CREST-accredited cybersecurity company with global medical device expertise
Deep understanding of IEC 81001-5-1 and U.S. FDA cybersecurity expectations
Proven experience supporting FDA 510(k) Cybersecurity Compliance
Audit-ready, evidence-based cybersecurity documentation
Trusted partner for medical device manufacturers and digital health innovators
Conclusion
Cybersecurity readiness and risk assessment are essential for medical device software in the United States. Aligning with IEC 81001-5-1 demonstrates a proactive commitment to patient safety, regulatory compliance, and product resilience.
Cyberintelsys delivers comprehensive IEC 81001-5-1 cybersecurity readiness and risk assessment services that provide:
Structured identification and management of cybersecurity risks
Regulatory-aligned documentation for FDA submissions
Enhanced patient safety and device reliability
Confidence in launching and maintaining secure medical device software
Partner with Cyberintelsys to achieve IEC 81001-5-1 cybersecurity readiness and medical device software compliance in the United States.
