SECURITY AND TRUST
Enterprise security and responsible AI, built into QualiVerse®.
QualiVerse is built for regulated MedTech environments, with information-security, quality-management and AI-governance controls designed into the platform and operating model.
QMB is ISO/IEC 27001 Certified
QMB has completed an ISO/IEC 27001 audit, confirming that our information security management system meets the international standard for protecting the confidentiality, integrity, and availability of data. This independent certification reflects our ongoing commitment to safeguarding customer and regulatory data, and the certificate is available on request.
View certificateQMB is ISO 13485 Certified
QMB has completed an ISO 13485 audit, confirming that our quality management system meets the international standard for medical device organizations. This independent certification reflects the same quality discipline we help our customers demonstrate in their own submissions, and the certificate is available on request.
View certificateHOW WE OPERATE
How QualiVerse® is built and governed
Security architecture
Detailed security architecture documentation is available as part of enterprise security review and due diligence. Reach out and our team will walk through our current posture directly.
- Hosting & data residency
- Encryption in transit & at rest
- Tenant & environment isolation
- Role-based access control
- Identity, SSO & MFA
- Centralized logging & monitoring
- Backup & business continuity
- Secrets & key management
- Network & application security
Secure development & vulnerability management
Our secure development lifecycle and vulnerability management practices are documented internally and available on request as part of enterprise due diligence.
- Secure SDLC & code review
- Vulnerability scanning
- Independent penetration testing
- Change control & deployment governance
- Incident response
- Security awareness training
Data governance & privacy
Your device data and evidence are not used to train shared models and are not exposed to other customers.
- Not used to train shared models
- Not exposed to other customers
- Closed regulatory sources, not the open web
Responsible AI
Outputs are grounded in real regulatory evidence and structured to FDA expectations, not generative guesswork.
- Every artifact reviewed by a regulatory expert
- Grounded in real regulatory evidence
- Extends your regulatory team, does not replace it
Security architecture
Detailed security architecture documentation is available as part of enterprise security review and due diligence. Reach out and our team will walk through our current posture directly.
- Hosting & data residency
- Encryption in transit & at rest
- Tenant & environment isolation
- Role-based access control
- Identity, SSO & MFA
- Centralized logging & monitoring
- Backup & business continuity
- Secrets & key management
- Network & application security
Have security or procurement questions?
Bring your specific security and procurement requirements, and our team will walk through our current documentation directly.