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.
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
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.
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.
Sustaining Security Over Time
After launch, proactive monitoring powered by AI dashboards ensures real-time
detection of new vulnerabilities and supports rapid incident response.
Cybersecurity Trends in Connected Health
Navigating global markets requires a deep understanding of evolving
cybersecurity regulations from major governing bodies.

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

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.

Threats by Connectivity Type
Different communication protocols have unique vulnerabilities that attackers exploit to gain access to devices.

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