Overview

In the United Kingdom, medical device software is increasingly connected, interoperable, and integrated with NHS and private healthcare IT environments. From Software as a Medical Device (SaMD) to embedded device software, remote monitoring platforms, and companion applications, cybersecurity is a critical component of patient safety, clinical effectiveness, and regulatory compliance.

Cyber threats targeting medical device software can lead to data breaches, service disruption, compromised device functionality, and patient harm. As a result, cybersecurity readiness and risk management are now essential requirements for manufacturers seeking market access and ongoing compliance.

IEC 81001-5-1 provides internationally recognised guidance for cybersecurity risk management of health and medical device software across the entire product lifecycle, including design, development, verification, validation, deployment, and post-market activities.

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 in the United Kingdom.

Importance of Cybersecurity Readiness for Medical Device Software

Medical device software is a high-value target due to its direct impact on patient safety, sensitive health data, and strict regulatory oversight under UKCA and MHRA requirements. Common cybersecurity risks include:

• Insecure authentication and access control in device software and companion applications

• Vulnerabilities in network, wireless, and remote connectivity

• Insecure APIs and cloud platforms supporting connected medical devices

• Weak encryption, key management, and firmware protection

• Supply chain and third-party component vulnerabilities

Cybersecurity readiness and risk assessment are essential to:

• Identify and manage cybersecurity risks throughout the device lifecycle

• Align with IEC 81001-5-1 risk management expectations

• Support UKCA marking, MHRA requirements, and NHS security expectations

• Protect patient safety, device performance, 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 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, SaMD, 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 cybersecurity risk assessment plan

2. Cybersecurity Risk Assessment

• Identification of threats, vulnerabilities, and attack surfaces affecting medical device software

• Threat modelling using STRIDE and MITRE ATT&CK for ICS

• Assessment of security controls protecting device safety, availability, and confidentiality

• Evaluation of third-party libraries, operating systems, and supply chain components

Output: Risk register with likelihood, impact, and patient safety relevance

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, clinical 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 UKCA marking and MHRA cybersecurity expectations

• Evidence aligned with recognised standards from ISO and NIST

• Clear traceability between identified risks, security controls, and mitigation actions

6. Validation & Ongoing Readiness

• Reassessment after remediation to confirm effective risk reduction

• Support for post-market cybersecurity monitoring and continuous improvement

Methodology Overview

1. Architecture Review: Analyse medical device software architecture and connectivity

2. Threat Modelling: Identify attack paths using STRIDE and MITRE ATT&CK for ICS

3. Risk Evaluation: Assess likelihood and impact on patient safety, effectiveness, and compliance

4. Technical Testing: Validate security controls through targeted testing

5. Reporting: Deliver regulator-ready cybersecurity risk documentation

Benefits of Cyberintelsys Cybersecurity Services

1. Regulatory Alignment

• Supports IEC 81001-5-1 cybersecurity risk management

• Enables compliance with UKCA, MHRA guidance, and NHS security requirements

• Aligns with international frameworks including ISO and NIST

2. Patient Safety & Device Integrity

• Reduces cybersecurity risks that could impact device performance or patient outcomes

• Protects sensitive patient and operational data

3. CREST-Accredited Expertise

• Assessments performed by CREST-certified professionals

• Ethical, standardised, and internationally recognised testing practices

4. Operational & Market Readiness

• Strengthens cybersecurity posture prior to UK market entry and clinical deployment

• Builds trust with healthcare providers, NHS organisations, and regulators

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 medical device data and analytics

Why Cyberintelsys in the United Kingdom?

• CREST-accredited cybersecurity company with strong UK healthcare experience

• Deep understanding of IEC 81001-5-1 and UK medical device cybersecurity expectations

• Proven experience supporting UKCA and MHRA-aligned cybersecurity assessments

• 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 Kingdom. Aligning with IEC 81001-5-1 demonstrates a proactive commitment to patient safety, regulatory compliance, and long-term 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 UKCA and MHRA requirements

• 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 Kingdom.