Securing the Future of Connected Medical Devices

Safeguarding Patient Care Through Uncompromising Cybersecurity

In today's interconnected healthcare landscape, every device is a lifeline. From IoMT and IoT to complex OT systems, ensuring the security of your products is a mandate for patient safety and business resilience. Our comprehensive cybersecurity services designed to Securing the Future of Connected Medical Devices.

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Our Services

Cybersecurity Strategy for Regulatory Successs

Our strategy is a continuous, two-phase journey that integrates security 
from initial design through the device's entire lifecycle, ensuring safety, 
compliance, and patient trust.

Threat Intelligence
Medical Device Penetration Testing
Navigating the complex landscape of medical device cybersecurity requires a structured and professional approach. Our penetration testing services provide exactly that.

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Regulatory Compliance
Threat Modeling and Vulnerability Assessments
We identify weaknesses, assess risks, prioritize defenses, and strengthen your security against evolving cyber threats.

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Threat Intelligence
SBOM & Vulnerability Assessments
Our services provide a clear path to compliance, safety, and market readiness, guiding you through each stage from design to deployment.

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Threat Intelligence
Medical Device Cybersecurity Validation & Testing
We integrate industry best practices with global regulatory standards to deliver a truly robust security framework, validating your device's resilience.

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Unified Risk Management
Medical Device CyberSecurity Assessment
Our assessments help you identify and address security gaps, providing a clear roadmap to compliance and a robust security posture.

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Secure by Design
Health Canada Penetration Testing Services
Our structured 3-phase approach ensures medical devices are secure, compliant, and resilient throughout their lifecycle — from design to postmarket monitoring.

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A Proactive Approach - Safeguarding the Future of Connected Health

By recognizing and addressing these specific threats, manufacturers, and healthcare providers can build more resilient systems and protect patient safety in a rapidly evolving digital landscape. By following this proven 3-step framework, medical device innovators can ensure their products are not only secure but also compliant with a complex global regulatory landscape.

72%

 

Healthcare data breaches in the last year :

Increase in major hacking incidents involving medical devices, highlighting the critical need for a security-first approach

Two-Phase Cybersecurity Roadmap

Pre & Post-Market Medical Device Cybersecurity Data Driven Insights.

We divide the device lifecycle into two critical phases to ensure comprehensive security coverage from concept to decommissioning. Integrating security from the ground up to ensure regulatory readiness and a secure launch. Ensuring ongoing protection and adaption to new and evolving threats throughout the devices operational life.

Phase 1 : Pre-Market Readiness
Activities

The pre-market phase involves a series of critical, front-loaded activities designed to build a secure foundation. This chart illustrates the relative importance and resource focus for each step, ensuring a robust and compliant device before it ever reaches a patient. Early investment in these areas significantly reduces downstream risks and costs.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

Phase 2 : Post-Market Surveillance
Cycle

Post-market security is not a linear process but a continuous cycle of vigilance. This radar chart visualizes the five core activities that form our ongoing surveillance strategy. A balanced and consistent effort across all five pillars is essential to maintain device integrity, respond to emerging threats, and ensure patient safety throughout the product's lifecycle.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

The Impact of a Proactive Strategy 

A holistic and measurable approach to medical device cybersecurity, suitable for executive, regulatory, or engineering audiences

Accelerated  
Time-to-Market

A proactive "Security by Design" approach significantly reduces regulatory review cycles compared to a reactive strategy where security is an afterthought.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

Mitigating Common Vulnerabilities

Proactive testing addresses the most common causes of breaches in connected medical devices, with a focus on preventing software and network-level exploits.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

Medical IoT Cybersecurity Insights

An overview of the evolving threat landscape for connected medical devices and its impact on patient care.

Healthcare Data  
Breaches

An increase in major hacking incidents involving medical devices highlights the critical need for a security-first approach.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

Primary Attack Types in  
Healthcare

This chart provides a breakdown of the most common types of cyberattacks targeting the healthcare sector.

Disclaimer note : Data for  charts is illustrative and does not represent actual statistics.

Most Vulnerable Medical Device Categories

An overview of the evolving threat landscape for connected medical devices. This data shows which categories are most frequently targeted.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

The Impact of a Proactive Strategy

A proactive "Security by Design" approach significantly reduces regulatory review cycles and mitigates common vulnerabilities.

Disclaimer note : Data for these charts is illustrative and does not represent actual statistics.

Pre-Market

Ensure Regulatory Readiness

The journey begins long before a device reaches a patient. Our focus is on embedding 
AI model safety and cybersecurity from design through validation.

Proactively identifying potential vulnerabilities and assessing their impact

Embedding robust security controls into the device's architecture and software from the earliest stages.

Creating a comprehensive inventory of all software components to enhance transparency and vulnerability management.

Identifying known weaknesses within the device's software and hardware.

Compiling thorough evidence of cybersecurity measures for regulatory bodies like the FDA.
Post-Market

Sustaining Security Over Time

After launch, proactive monitoring powered by AI dashboards ensures real-time 
detection of new vulnerabilities and supports rapid incident response.

Continuously scanning for new threats and vulnerabilities that could affect deployed devices.

Developing clear protocols for detection, containment, eradication, and recovery in the event of a security breach.

Delivering timely security updates and patches to address new vulnerabilities and evolving threats.

Monitoring device performance and security in real-world environments to identify and address issues proactively.

Ensuring that devices are securely retired, and sensitive data is properly handled at the end of their lifecycle.

Cybersecurity Trends in Connected Health 

Navigating global markets requires a deep understanding of evolving 
cybersecurity regulations from major governing bodies.

Medical AI
SaMD & Wearable Device Threats

Cyber threats targeting Software as a Medical Device (SaMD) and consumer wearables often focus on data integrity and patient privacy.

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IoMT Network & Gateway Attacks

The broader IoMT network is a prime target for attackers seeking a foothold to disrupt hospital operations and access a wide range of devices.

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Threats by Connectivity Type

Different communication protocols have unique vulnerabilities that attackers exploit to gain access to devices.

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Bluetooth & BLE

The broader IoMT network is a prime target for attackers seeking a foothold to disrupt hospital operations and access a wide range of devices.

Ready to move from uncertainty to a position of confidence?

Contact us today to begin your Cybersecurity Assessments with a clear, compliant, and actionable plan.

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