Our Clients
Trusted by essential services, critical suppliers and organisations across health, technology and digital services.
Professional vulnerability assessment and security testing
Our CREST certified penetration testing services help identify security vulnerabilities before malicious actors can exploit them. We simulate real-world attacks to strengthen your defenses and protect your critical systems and data.
Ensuring Security Through Penetration Testing
Our Penetration testing is customisable to fit the specific needs and requirements for digital health organisations, which makes it a valuable tool to identify and mitigate vulnerabilities in your computer systems, networks, and web applications.
LEADING TESTERS
Our penetration testing services provide comprehensive assessments for business, digital health and medical devices to identify and address potential security risks.
TAILORED SOLUTIONS
We offer customised penetration testing solutions to meet the unique needs of digital health organisations. We meet standards such as FDA, EUMDR and more.
How It Works
Comprehensive cybersecurity testing for medical devices, Software as Medical Device (SaMD), and healthcare systems to ensure patient safety, regulatory compliance, and data protection.
FDA & EU MDR Compliance
Meet FDA cybersecurity guidance and EU MDR requirements with comprehensive penetration testing that addresses IEC 62304, IEC TR 60601-4-5:2021, and MDCG 2021-5 Rev.1 standards for medical device cybersecurity.
Patient Safety & Data Protection
Protect patient health information (PHI) and ensure medical device functionality cannot be compromised by cyberattacks. Identify vulnerabilities that could impact patient care or expose sensitive healthcare data.
Software as Medical Device (SaMD) Testing
Specialized penetration testing for SaMD applications, mobile health apps, and cloud-based medical software. Ensure your digital therapeutics and diagnostic software meet cybersecurity requirements.
ISO 14971 Risk Management
Integrate cybersecurity risk assessment into your ISO 14971 risk management process. Identify, analyze, and mitigate security risks throughout the medical device lifecycle.
Faster Market Access & Approval
Accelerate FDA 510(k) submissions and CE marking processes with comprehensive cybersecurity documentation. Demonstrate proactive security measures to regulatory bodies.
IoMT & Connected Device Security
Secure Internet of Medical Things (IoMT) devices, wearables, and connected medical equipment. Test network communications, device authentication, and data transmission security.
Specialised Medical Device Testing
Medical Device Categories
Implantable cardiac devices (pacemakers, ICDs)
Insulin pumps and continuous glucose monitors
MRI machines and imaging equipment
Ventilators and life support systems
Surgical robots and navigation systems
SaMD & Digital Health
Mobile health (mHealth) applications
AI-powered diagnostic software
Digital therapeutics (DTx) platforms
Telemedicine and remote monitoring
Clinical decision support systems
FDA
Cybersecurity in Medical Devices
Secure Your Medical Devices Today
Get expert penetration testing for your medical devices and SaMD applications. Ensure patient safety, regulatory compliance, and cybersecurity resilience.
Services
WE HAVE A VARIETY OF SERVICES SPECIFIC TO ENSURING THE SECURITY OF YOUR MEDICAL DEVICES.
Medical device cyber security refers to the protection of medical devices from unauthorised access, use, disclosure, disruption, modification, or destruction. Cyber security for medical devices involves protecting these devices from cyber threats like hacking, malware, and unauthorised access. As medical devices become more connected, they face risks similar to traditional IT systems. Ensuring cybersecurity means safeguarding both the functionality of the devices and the sensitive patient data they handle. This includes implementing encryption, adhering to regulations like HIPAA and FDA guidelines, and continuously monitoring for threats. The goal is to ensure these devices remain secure, reliable, and safe for patient care.
