1) Does RATIFY replace clinicians?
No. RATIFY is an assurance and monitoring layer that supports clinical judgment. It tracks AI and human outputs in real time to flag potential errors so clinicians can make safer decisions. RATIFY strengthens clinical oversight through AI Assurance and Monitoring — it never replaces human expertise. envisionit.ai
2) What problem does RATIFY solve?
It provides post-market surveillance (PMS) and continuous monitoring for AI in line with the EU AI Act (Article 71) and updated FDA expectations—so teams can evidence safety, performance and compliance in production. RATIFY closes the post-deployment gap in AI Assurance by continuously tracking model safety, performance, and compliance in production. envisionit.ai
3) What makes RATIFY “ethical by design”?
It focuses on real-world validation, monitoring, explainability and quality assurance rather than “black-box” outputs, helping organisations minimise risk and prove consistency over time. By embedding AI Assurance and Monitoring as core features, it ensures ethical AI in healthcare beyond initial validation. envisionit.ai
4) How does RATIFY help with regulatory submissions?
RATIFY automates AI Assurance reporting by generating the technical and scientific evidence that hospitals and vendors need for validation, clinical trials, and regulatory filings. It streamlines compliance with ISO 13485, EU AI Act, and FDA requirements, reducing time and cost to prove safety and effectiveness. envisionit.ai
5) Is the company quality-certified?
Yes. Envisionit Deep AI has publicly announced ISO 13485 certification, the international standard for medical-device quality management systems. This certification underscores our commitment to AI quality, safety, and regulatory compliance. LinkedIn
6) What about privacy laws like GDPR/POPIA?
Envisionit states a commitment to GDPR and POPIA compliance; RATIFY supports AI governance and privacy compliance by ensuring that all monitoring, evidence generation, and data flows remain secure and policy driven. envisionit.ai
7) How does RATIFY address bias and fairness?
Bias monitoring is a core pillar of AI Assurance. RATIFY enables sub-group analysis and ongoing performance checks across populations, sites, and devices to detect drift or differential outcomes early, helping clinicians and AI developers intervene before patient care is impacted. envisionit.ai
8) Is the system explainable?
Yes. RATIFY makes AI results explainable, auditable, and clinician-friendly. Each finding is paired with clinical context so users can understand, challenge, and verify outputs — reinforcing transparency and accountability in AI-supported care. envisionit.ai+1
9) Who is accountable if an AI result is wrong?
Clinical accountability always remains with clinicians and providers. RATIFY supports AI governance by surfacing issues in real time, logging evidence, and maintaining traceable audit trails so organisations can demonstrate responsible oversight and compliance. envisionit.ai
10) Can RATIFY help me choose the right AI?
Yes. RATIFY provides AI Assurance-based benchmarking, comparing and evaluating third-party AI tools with real-world data to help hospitals select solutions that meet strict scientific and regulatory standards. envisionit.ai
11) What if model performance drifts after go-live?
RATIFY’s continuous AI Monitoring detects performance drift in real time, supports post-market surveillance, and preserves a full audit trail: enabling early intervention, documentation, and corrective action when required. envisionit.ai
12) How does RATIFY integrate with existing systems?
RATIFY integrates seamlessly into existing PACS, RIS, and AI platforms through secure APIs. It monitors model outputs in real time without disrupting existing clinical workflows, enabling hospitals to scale AI Monitoring efficiently.
13) Can RATIFY be used beyond radiology?
Yes. While RATIFY originated in radiology, its AI Assurance and Monitoring framework applies equally to pathology, cardiology, oncology, and other diagnostic domains, ensuring safety and accountability across the healthcare ecosystem.
