Cybersecurity for Medical Devices and Healthcare Equipment

As medical devices become more connected through IoT and network integration, cybersecurity is a top priority for manufacturers and healthcare providers. With the rise of Software as a Medical Device (SaMD) and the integration of AI-Enabled and Machine Learning technologies, ensuring the security of these advanced systems is crucial.  While the benefits of real-time data access, remote monitoring, and personalized care are immense, they also introduce serious risks. Cyberattacks on medical devices can compromise patient data, cause device malfunctions, and even lead to life-threatening consequences. 

Intertek Connected World offers comprehensive cybersecurity solutions tailored to the unique challenges of medical devices, SaMD, and healthcare systems incorporating AI/ML technologies. By engaging early in the product development lifecycle, we help you adopt a proactive approach to cybersecurity, avoiding costly re-work, regulatory delays, and ensuring faster time-to-market. Our services help you meet stringent regulatory requirements, secure your products, and protect patient safety. With decades of experience and technical expertise, we support you throughout the product lifecycle—from design to post-market surveillance. 

Our Cybersecurity Services for Medical Devices 

Penetration Testing & Vulnerability Assessments 

We simulate real-world cyberattacks to identify and address vulnerabilities in your devices and healthcare systems.  Regularly performing these services helps ensure your devices remain secure against evolving threats, protecting your reputation and safeguarding patient safety. 

• The Vulnerability Assessment process ensures that devices contain no known security weaknesses that could be exploited by attackers. We assess them against industry-standard databases such as CWE (Common Weakness Enumeration) and CVE (Common Vulnerability Enumeration). Each vulnerability is evaluated based on its severity and potential impact, helping you prioritize remediation efforts and ensuring compliance with cybersecurity standards such as UL 2900 and regulatory requirements.  
• Our structured Penetration Testing evaluates the resilience of your medical devices against cyberattacks. We identify and test vulnerabilities that could allow attacks such as unauthorized access, denial of service, or privilege escalation. These tests follow industry-standard methodologies and assess your devices’ ability to maintain secure operations during and after testing. The results help prioritize security improvements, ensuring compliance with industry standards and regulatory requirements like those from the FDA.

UL 2900-2-1 Certification 

We provide testing and certification services for ANSI/UL 2900-2-1, a globally recognized standard for software cybersecurity in healthcare devices. This certification demonstrates that your devices meet the required cybersecurity controls to protect against unauthorized access and attacks.  It demonstrates your device's cybersecurity robustness, building trust with regulators and customers alike. 

Cybersecurity Risk Management 

Building robust cybersecurity starts with effective risk management. Our services include: 

• Cybersecurity Risk Assessments: We evaluate your product's security posture against standards like ISO 14971 and AAMI TIR57, ensuring all potential risks are identified and managed throughout the development lifecycle.
• Threat Modeling: Identify potential attack vectors and assess how your device can defend against them, reducing risks from the design phase onward.

Secure Development Lifecycle (IEC 81001-5-1) 

Integrate cybersecurity best practices into every stage of your device's development with our support for the IEC 81001-5-1 standard. This standard ensures that security is embedded in the design, development, testing, and deployment of medical software and hardware.  We offer: 

• Training: Comprehensive training for IEC 81001-5-1 to help your teams understand and implement the security processes and activities outlined in the IEC 81001-5-1 standard.
• Custom Workshops: Tailored workshops designed to address your specific needs, focusing on secure development practices and lifecycle management based on IEC 81001-5-1.
• Assessment Services: We provide complete assessment services to evaluate your compliance with IEC 81001-5-1, ensuring your development processes align with industry standards and regulatory expectations.

Regulatory Compliance Consulting 

Meeting global cybersecurity regulations is critical for market access. Our team provides expert guidance to help you achieve compliance with: 

• FDA Cybersecurity Guidelines: Ensure compliance with the FDA’s Cybersecurity Guidelines, critical for devices intended for the U.S. market.
• EU MDR: Meet the European Union’s Medical Device Regulation (MDR) cybersecurity requirements.
• Global Standards: Stay compliant with international cybersecurity standards, including IEC 62443, IEC 81001-5-1, and UL 2900-2-1, ensuring a robust security framework.

Why Intertek for Medical Device Cybersecurity? 

• Industry Expertise: We have extensive experience working with medical device manufacturers to address cybersecurity threats while meeting global regulatory requirements.
• End-to-End Cybersecurity Solutions: From risk assessments and penetration testing to regulatory consulting and certification, we provide a full suite of cybersecurity services for medical devices.
• Fast and Reliable: Our streamlined processes help you achieve compliance quickly without compromising on security, enabling you to launch secure, compliant products in a competitive market.

In a world of connected healthcare, cybersecurity is paramount to patient safety and trust. Intertek Connected World is your partner in securing medical devices against emerging cyber threats while ensuring compliance with the latest regulatory standards. Contact us to learn more about our tailored cybersecurity services for medical devices and healthcare systems.