solutions
Cyber Risk Assessment
In today’s interconnected world, cybersecurity is a critical concern for both product software, such as Software in Medical Devices (SiMD), Software as a Medical Device (SaMD), and Multiple Function Devices, as well as non-product Operational Technology (OT) environments. These systems are increasingly targeted by cyber threats that can compromise patient safety, operational integrity, and regulatory compliance. Qualified Data Systems (QDS) offers a comprehensive Cybersecurity Risk Assessment Solution designed to identify, evaluate, and mitigate cybersecurity risks across both product and non-product environments. Our solution ensures that your systems are resilient against cyber threats and meet stringent regulatory requirements.
Solution Activities
Comprehensive Risk Assessment for Product Software
- Threat Modeling and Attack Surface Analysis: QDS conducts detailed threat modeling to identify potential attack vectors and vulnerabilities specific to SiMD, SaMD, and Multiple Function Devices. Our attack surface analysis evaluates the entry points that could be exploited by cyber threats, providing a clear picture of your product’s risk landscape.
- Risk Identification and Evaluation: We systematically identify and evaluate cybersecurity risks associated with your product software, taking into account factors such as data sensitivity, user access, and communication channels. Our risk assessment prioritizes risks based on their potential impact and likelihood, helping you focus on the most critical vulnerabilities.
- Regulatory Compliance Assessment: Our risk assessment process ensures that your product meets the cybersecurity requirements of relevant regulatory bodies, including FDA premarket cybersecurity guidelines, IEC 62304, and ISO/IEC 27001. We help you align your risk management practices with these standards, reducing the likelihood of compliance issues.
Cybersecurity Risk Assessment for Non-Product OT Environments
- OT Asset Inventory and Classification: QDS begins by developing a comprehensive inventory of your OT assets, including hardware, software, and network components. We classify these assets based on their criticality to your operations, helping you understand the potential impact of cybersecurity risks on your OT environment.
- Vulnerability Assessment and Risk Analysis: We perform vulnerability assessments to identify weaknesses in your OT systems, such as outdated software, weak access controls, or unpatched vulnerabilities. Our risk analysis evaluates the potential impact of these vulnerabilities on your operations, safety, and compliance.
- Industrial Control System (ICS) Security Assessment: For environments with ICS, SCADA, or other OT systems, QDS provides specialized security assessments to identify risks unique to these systems. Our assessments include evaluating network segmentation, communication protocols, and device configurations to ensure that your OT environment is protected against cyber threats.
Risk Mitigation Strategies and Action Plans
- Tailored Risk Mitigation Strategies: Based on our risk assessment findings, QDS develops tailored risk mitigation strategies that address the specific vulnerabilities of your product and OT environments. Our strategies include implementing security controls, enhancing access management, and securing data flows.
- Prioritized Action Plans: We provide a prioritized action plan that outlines the steps needed to mitigate identified risks. Our plans are designed to be actionable and achievable, ensuring that your organization can effectively reduce its cybersecurity risk while maintaining operational efficiency.
- Security Controls Implementation: QDS assists in the implementation of security controls recommended in the risk mitigation strategy. This includes deploying firewalls, intrusion detection systems, encryption, and other security technologies that protect your systems from cyber threats.
Continuous Monitoring and Risk Management
- Real-Time Risk Monitoring: QDS offers continuous monitoring services to track cybersecurity risks in real-time. Our monitoring solutions include security information and event management (SIEM), intrusion detection systems (IDS), and endpoint protection tailored to both product and OT environments.
- Incident Response Planning and Support: In the event of a cybersecurity incident, QDS provides incident response planning and support to help you quickly contain and mitigate the threat. Our incident response plans are designed to minimize downtime, protect critical assets, and ensure compliance with regulatory reporting requirements.
- Ongoing Risk Assessment and Review: Cybersecurity risks are constantly evolving, and so should your risk management practices. QDS provides ongoing risk assessment and review services to ensure that your risk management strategies remain effective and up-to-date. We help you adapt to new threats and changing regulatory requirements, ensuring long-term resilience.
Regulatory and Audit Support
- Regulatory Documentation and Compliance: QDS assists in preparing the necessary documentation to demonstrate compliance with cybersecurity regulations. Our services include developing risk management plans, security testing reports, and other documentation required for regulatory submissions and audits.
- Audit Preparation and Remediation: We provide support during regulatory audits, including pre-audit assessments, documentation reviews, and remediation planning. QDS ensures that your organization is fully prepared for audits and can demonstrate compliance with cybersecurity requirements.
- Global Standards Alignment: Our risk assessment solution aligns with global cybersecurity standards, including ISO 27001, NIST Cybersecurity Framework, and IEC 62443. QDS helps you achieve and maintain compliance with these standards, facilitating global market access and ensuring best-in-class security practices.
Industry Focus
QDS specializes in providing Cybersecurity Risk Assessment solutions for the following sectors:
- Medical Devices (SiMD, SaMD, and Multiple Function Devices): Ensuring the cybersecurity of software integrated into medical devices and standalone medical software, protecting patient safety and ensuring regulatory compliance.
- Operational Technology (OT) Environments: Addressing the unique cybersecurity challenges of OT environments, including industrial control systems, SCADA, and other critical infrastructure, ensuring operational continuity and safety.
Value Proposition
QDS’s Cybersecurity Risk Assessment Solution offers the following benefits:
Our solution identifies and evaluates cybersecurity risks early, allowing you to take proactive steps to mitigate vulnerabilities before they can be exploited.
We ensure that your cybersecurity practices align with regulatory requirements, reducing the risk of non-compliance and facilitating smoother regulatory approvals.
By implementing tailored risk mitigation strategies, QDS helps you strengthen the security and resilience of your product and OT environments against cyber threats.
Our continuous monitoring and ongoing risk management services ensure that your systems remain protected against evolving threats, supporting long-term security and operational integrity.