Cybersecurity in Medical Devices

We have extensive experience in the field of cybersecurity, helping our clients meet their needs.

Do you want to obtain CE marking for your medical device in accordance with the cybersecurity requirements under MDR/IVDR? Are you seeking FDA authorization for your medical device and want to ensure compliance with its demanding cybersecurity requirements? Do you need an independent security validation report for your medical device?

At SQS, we guarantee the cybersecurity of your systems and products through an independent team of specialists who carry out consulting, analysis, and exhaustive testing. Our approach ensures that your system’s security requirements are correctly designed and implemented, mitigating risks and ensuring robust protection against cyber threats. Through our testing and analysis, we validate that your product meets the highest security standards, guaranteeing its integrity and safe operation in critical environments.

We have the tools and experience to assess the overall security of your medical device. Our team is certified in cybersecurity.

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Implementation Cybersecurity Requirements

We offer assistance in implementing cybersecurity requirements in accordance with IEC TR 60601-4-5, MDCG guidance 2019-16 rev.1, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions from the FDA, and other regulatory standards and application guidelines, aimed at medical device manufacturers. We help integrate security controls into connected components, such as authentication, access control, and data protection, ensuring regulatory compliance and patient protection from the product design stage.

STRIDE Threat Model

We offer a service for implementing the STRIDE-based threat model, focused on training the client’s team in this methodology and supporting them in its practical application on specific systems or products. Through training sessions and guided workshops, we help identify potential threats from the early stages of development, structuring the analysis by categories such as impersonation, data manipulation, repudiation, information disclosure, denial of service, and privilege escalation. This approach allows us to strengthen the secure design of the system and establish mitigation measures from the beginning of the life cycle.

Cybersecurity Risk Management

We offer a cybersecurity risk management implementation service where we identify the security measures that must be (or are already) implemented in compliance with specific standards, guidelines, and regulatory requirements (GDPR, HIPAA, MDCG 2019-16, FDA guidelines, etc.). This consists of the development of:

Cybersecurity Risk Management Plan
Cybersecurity Risk Analysis
Risk Management Report

Vulnerability Analysis and Pentesting

We offer a comprehensive vulnerability analysis and penetration testing (pentesting) service that consists of:

Identification of potential vulnerabilities
Exploitation of detected vulnerabilities
Measurement of the impact of detected vulnerabilities
Detailed and independent report on the results of the tests performed

Cybersecurity Lifecycle Implementation

We help you implement the cybersecurity lifecycle according to IEC/TR 81001-5-1. We start by training the customer’s team on the standard and its key principles, followed by a review of existing documentation and processes. This allows us to identify gaps and establish secure practices throughout the product lifecycle, facilitating compliance with regulations such as MDR/IVDR and FDA.