MEDICAL DEVICE TESTING
MEDICAL DEVICE CYBERSECURITY
Protecting patient safety starts with securing the devices that keep healthcare running.
Today’s medical devices are smart, connected—and increasingly targeted. Cybersecurity is no longer just about safeguarding data; it’s about protecting lives, maintaining clinical uptime, and meeting evolving global regulatory requirements.
Lightship helps medical device manufacturers navigate this complex cybersecurity landscape with clarity and confidence—so you can stay compliant, stay secure, and stay focused on patient care.
Why It Matters
A compromised medical device can mean more than a data breach. It can lead to:
- Patient harm from device malfunction or incorrect dosing.
- Privacy violations exposing sensitive health records.
- Operational disruption from ransomware attacks targeting hospitals and clinics.
Regulatory bodies like the FDA, EMA, and NMPA require strict cybersecurity measures. Non-compliance can result in penalties, recalls, or bans. We make sure you meet—and exceed—those requirements.
Our Services
Lightship Security is an IEEE ICAP–accredited medical device cybersecurity testing lab, authorized under the IEEE 2621 program for independent medical device security evaluations. We deliver end-to-end cybersecurity services tailored to the unique needs of modern medical devices.
Security Strategy and Compliance
We help manufacturers and healthcare providers align with global cybersecurity standards and regulatory expectations. From FDA cybersecurity guidance to ISO/IEC frameworks and international best practices, our experts ensure your devices are secure, compliant, and ready for submission.
Threat Modeling and Risk Management
Identify and mitigate vulnerabilities early in the development cycle.
We work closely with your engineering teams to:
- Build robust, actionable threat models
- Define and verify security requirements
- Validate risk control measures throughout the entire product lifecycle
Cybersecurity Testing
Our testing services go far beyond basic checklists—providing deep, technical assurance backed by independent, accredited expertise.
Vulnerability Analysis
- Robustness and fuzz testing
- Static and dynamic code analysis
Attack Surface Review
- Closed-box vulnerability scanning
- Software composition analysis (SCA)
Penetration Testing
- Independent, rigorous testing that uncovers and exploits real-world weaknesses
Where We Take Our Clients
- Lower risk exposure for patients, providers, and manufacturers
- Stronger compliance posture with global regulators and certification bodies
- Greater resilience against ransomware, cyberattacks, and operational disruptions
Your devices save lives.
We make sure they stay secure.
MEDICAL DEVICE CYBERSECURITY
Protecting patient safety starts with securing the devices that keep healthcare running.
Today’s medical devices are smart, connected—and increasingly targeted. Cybersecurity is no longer just about safeguarding data; it’s about protecting lives, maintaining clinical uptime, and meeting evolving global regulatory requirements.
Lightship helps medical device manufacturers navigate this complex cybersecurity landscape with clarity and confidence—so you can stay compliant, stay secure, and stay focused on patient care.
Why It Matters
A compromised medical device can mean more than a data breach. It can lead to:
- Patient harm from device malfunction or incorrect dosing.
- Privacy violations exposing sensitive health records.
- Operational disruption from ransomware attacks targeting hospitals and clinics.
Regulatory bodies like the FDA, EMA, and NMPA require strict cybersecurity measures. Non-compliance can result in penalties, recalls, or bans. We make sure you meet—and exceed—those requirements.
Our Services
Lightship Security is an IEEE ICAP–accredited medical device cybersecurity testing lab, authorized under the IEEE 2621 program for independent medical device security evaluations. We deliver end-to-end cybersecurity services tailored to the unique needs of modern medical devices.
Security Strategy and Compliance
We help manufacturers and healthcare providers align with global cybersecurity standards and regulatory expectations. From FDA cybersecurity guidance to ISO/IEC frameworks and international best practices, our experts ensure your devices are secure, compliant, and ready for submission.
Threat Modeling and Risk Management
Identify and mitigate vulnerabilities early in the development cycle.
We work closely with your engineering teams to:
- Build robust, actionable threat models
- Define and verify security requirements
- Validate risk control measures throughout the entire product lifecycle
Cybersecurity Testing
Our testing services go far beyond basic checklists—providing deep, technical assurance backed by independent, accredited expertise.
Vulnerability Analysis
- Robustness and fuzz testing
- Static and dynamic code analysis
Attack Surface Review
- Closed-box vulnerability scanning
- Software composition analysis (SCA)
Penetration Testing
- Independent, rigorous testing that uncovers and exploits real-world weaknesses
Where We Take Our Clients
- Lower risk exposure for patients, providers, and manufacturers
- Stronger compliance posture with global regulators and certification bodies
- Greater resilience against ransomware, cyberattacks, and operational disruptions
Your devices save lives.
We make sure they stay secure.