Cybersecurity in Medical Devices

Cybersecurity is no longer a one-time regulatory hurdle—it is a continuous, lifecycle responsibility. As medical devices become increasingly connected, FDA expectations now extend beyond premarket documentation to include ongoing monitoring, vulnerability management, and real-world risk response.

RQMIS, in partnership with Twin Tech Labs, delivers an integrated cybersecurity solution that combines regulatory expertise with a modern, AI-driven security operations platform. This approach enables medical device and SaMD companies to meet both premarket and post-market cybersecurity expectations—without building internal security teams or relying heavily on contractors.

How Can RQMIS and Twin Tech Labs Support Your Medical Device Cybersecurity Needs?

Web and Mobile Application Penetration Testing: Proactively identify and address vulnerabilities in your medical device applications through rigorous testing methodologies.
Security and Information Event Management (SIEM) Solutions: Implement advanced SIEM tools to monitor, detect, and respond to potential security threats in real-time.
Remote Security Operations Center (SOC): Our dedicated SOC team works seamlessly with your IT organization to rapidly detect, triage, and aid in the remediation of security incidents—providing 24/7 vigilance.
Consulting on Cybersecurity Requirements and Best Practices: Navigate complex regulatory landscapes with expert guidance on FDA requirements, cybersecurity frameworks, and industry best practices.

A Scalable, Continuous Cybersecurity Model

Our expanded cybersecurity offering is powered by Arca, a self-hosted security operations platform, and Nemesis, an advanced breach and attack simulation engine. Together, they allow us to deliver:

Automated penetration testing
Real-time compliance evidence generation
Continuous post-market monitoring
AI-driven threat detection and investigation

This model replaces fragmented, manual cybersecurity efforts with a consistent, scalable solution aligned to regulatory expectations.

How We Support Your Cybersecurity Needs

Premarket Cybersecurity Strategy & FDA Submissions

We support development of cybersecurity documentation aligned with FDA guidance, including:

Threat modeling and risk assessments
Secure architecture and design review
Software Bill of Materials (SBOM) planning
Vulnerability management processes
Post-market cybersecurity planning

Automated Penetration Testing & Attack Simulation

Using Nemesis, we simulate real-world attack scenarios across network, infrastructure, web applications, and APIs.

28+ attack scenarios mapped to MITRE ATT&CK techniques
Autonomous validation of detection and response capabilities
Continuous testing loops to strengthen security posture

Mobile application testing is supported through targeted engagements when needed.

Compliance Evidence—Generated from Live Data

Arca produces auditor-ready reports based on real system activity—not static documentation.

Supported frameworks include:

HIPAA
NIST Cybersecurity Framework (aligned with FDA expectations)
SOC 2
PCI DSS

This eliminates manual evidence collection and ensures audit readiness at any time.

Continuous Post-Market Cybersecurity Monitoring

To meet post-market surveillance expectations, Arca enables ongoing visibility into system activity:

Log collection across endpoints, cloud environments, containers, and services
Continuous SIEM-based detection rules
AI-driven investigation of every alert before human review
Structured case creation with full audit trails
Optional automated response actions (e.g., blocking threats, disabling accounts)

This provides a turnkey solution for demonstrating ongoing cybersecurity monitoring and risk management.

Expert Review & Regulatory Integration

Technology alone isn’t enough. RQMIS bridges the gap between cybersecurity data and regulatory expectations by:

Interpreting results for FDA submissions and audits
Supporting remediation and risk-based decision-making
Integrating cybersecurity into quality systems and post-market processes

A Better Way to Deliver Cybersecurity

This approach allows clients to:

Maintain full control of their data through a self-hosted platform
Avoid per-usage or consumption-based pricing models
Reduce reliance on external cybersecurity contractors
Achieve consistent, repeatable, and audit-ready cybersecurity practices

Get Started

Whether you are preparing for FDA submission or strengthening your post-market surveillance program, RQMIS can help you implement a modern, scalable cybersecurity strategy.