Layer 8 Security can help with all regulatory cybersecurity testing requirements. We’ll ensure that your tests are complete and reportable to the FDA so your device and/or software gets approved with the first submission, whether it’s a PMA, 510(k), or DeNovo.
Other services we provide in this realm are ISO 27001 readiness & certification, NIST assessments, and Information Security Program Management to bring a holistic approach to the organization in its entirety, not just the device.
Learn more about our multifaceted approach, including:
- Threat Modeling
- Software Composition Analysis
- Penetration testing to bolster defenses:
- Social Engineering
- Information Security Program Management
- Information Security Risk Assessment - NIST, ISO, etc
- Third-party vendor management
- Security Operations and Monitoring
- Tabletop Testing