Cybersecurity is no longer just a checkbox for FDA submission—it is a continuous, lifecycle requirement.
As medical devices become more connected and software-driven, they are increasingly exposed to evolving cyber threats. Regulators now expect manufacturers to not only identify vulnerabilities during development, but also demonstrate how those risks will be monitored, managed, and mitigated after commercialization.
At RQMIS, we help you build and execute a complete cybersecurity testing and post-market surveillance strategy—combining regulatory expertise with an AI-driven security operations platform to deliver continuous, audit-ready cybersecurity.
Why Cybersecurity Planning Matters More Than Ever
Cybersecurity risks can emerge at any stage of the product lifecycle—from development and clinical trials to post-market use in real-world environments.
FDA requirements now explicitly mandate that manufacturers:
- Include cybersecurity risk management in premarket submissions
- Provide a post-market cybersecurity monitoring plan
- Continuously identify, assess, and remediate vulnerabilities
- Maintain lifecycle documentation and security controls
Failure to include a robust post-market plan can result in submission delays or refusal-to-accept decisions.
A Modern Approach to Cybersecurity Testing & Monitoring
RQMIS, in partnership with Twin Tech Labs, delivers a next-generation approach powered by:
- Arca – a self-hosted security operations platform
- Nemesis – an automated breach and attack simulation engine
This enables a shift from manual, one-time testing to continuous, automated cybersecurity validation and monitoring.
What We Deliver
1. Cybersecurity Testing That Reflects Real-World Threats
We go beyond traditional vulnerability scans to simulate how attackers actually behave.
- Automated penetration testing across network, infrastructure, web, and APIs
- 28+ attack scenarios mapped to MITRE ATT&CK techniques
- Continuous validation of detection and response capabilities
- Identification of exploitable weaknesses before they reach patients
This approach strengthens both your premarket submission evidence and your real-world security posture.
2. Compliance Evidence—Generated Automatically
One of the biggest bottlenecks in cybersecurity submissions is assembling documentation.
We eliminate that.
Arca generates auditor-ready reports directly from live system data, supporting:
- NIST Cybersecurity Framework (aligned with FDA expectations)
- HIPAA
- SOC 2
- PCI DSS
No screenshots. No spreadsheets. No scrambling before audits.
3. Post-Market Cybersecurity Monitoring (Turnkey)
FDA expects manufacturers to actively monitor and respond to cybersecurity risks after commercialization.
We provide a ready-to-deploy solution:
- Continuous log collection across endpoints, cloud, and container environments
- SIEM-based detection rules running 24/7
- AI-driven investigation of every alert before human review
- Structured case management with full audit trails
- Optional automated response actions (e.g., blocking threats, disabling accounts)
This gives you real-time visibility and defensible evidence of ongoing cybersecurity oversight.
4. Integrated Regulatory Strategy & Documentation
Technology alone doesn’t get you through FDA.
RQMIS ensures everything ties back to regulatory success:
- Cybersecurity risk management plans for 510(k), De Novo, and PMA submissions
- Threat modeling and architecture documentation
- SBOM strategy and vulnerability management processes
- Post-market surveillance planning aligned with FDA Section 524B requirements
- Submission-ready documentation and audit support
From One-Time Testing to Continuous Cybersecurity
Traditional cybersecurity models rely on periodic testing and external contractors.
Our approach delivers:
- Continuous monitoring instead of point-in-time assessments
- Consistent, repeatable testing across environments
- Scalable cybersecurity without increasing headcount
- Full data ownership through a self-hosted platform
This is how modern medical device companies meet Total Product Lifecycle (TPLC) cybersecurity expectations.
The Outcome
With RQMIS, you can:
- Accelerate FDA submission readiness
- Demonstrate a compliant post-market cybersecurity program
- Reduce risk of vulnerabilities reaching patients
- Maintain audit-ready cybersecurity evidence at all times
- Scale your cybersecurity capabilities without building internal teams
Get Started
If you are developing a connected medical device or SaMD product, now is the time to build a cybersecurity strategy that extends beyond submission—and into real-world performance.