Built-in traceability for smarter, faster risk management
Cira Health helps medical device teams create, maintain, and update risk analyses with confidence. Every risk decision is traceable, auditable, and aligned with FDA and international standards—without adding complexity to your existing QMS.
The Problems Teams Face—and
How Cira Helps
Cira transforms complex data into actionable knowledge for safer, faster decision-making.
Risk analysis takes too long
Analysts spend weeks digging through FDA databases, reusing old spreadsheets, and manually writing hazard-cause-harm chains.
- ✓Using AI to surface hazards from FDA MAUDE/TPLC data
- ✓Automatically generating draft risk analyses
Risks don't clearly map to product versions
QMS tools track documents—but not which hardware, software, or labeling version a risk applies to.
- ✓Making risk files configuration-aware
- ✓Tying risks directly to product versions
Teams use inconsistent terminology
Similar hazards are described differently across teams, causing confusion and audit findings.
- ✓Using standardized, FDA-aligned hazard language
- ✓Ensuring consistent, FDA/ISO-based taxonomies
Cira makes traceability simple and automatic
You always know where a risk came from, what it affects, and why it changed.
Every hazard links back to trusted FDA data (MAUDE, TPLC, and other public safety sources)
Every edit is tracked—who made it, when, and what changed (full audit log for each PHA, FMEA, and URRA update)
Every version stays connected to the exact hardware, software, or labeling configuration it applies to
Why Cira's Customization Is Different
Purpose-built for regulated medical device environments, Cira combines a proven risk foundation with responsible AI—without sacrificing transparency or control.
Built on a Proven Core
Your solution isn't built from scratch. It's layered on top of Cira's validated risk engine reducing cost, implementation time, and delivery risk.
Deep Expertise Where It Matters
- •Structuring complex safety and clinical data
- •Mapping multi-source inputs into clear risk models
- •Applying AI responsibly in regulated environments
- •Maintaining auditability and human oversight
A Managed Platform—Not a Hand-Off
Cira doesn't deliver code and disappear.
- •Runs securely on the Cira platform
- •Receives ongoing updates and improvements
- •Evolves with regulatory guidance, AI, and security enhancements
Built for Regulatory Reality & AI Compliance
Every AI-assisted insight is:
- •Traceable to a trusted source
- •Reviewable by a human
- •Logged for audit and compliance
How Cira Fits Into Your Workflow
Our Customized AI Solution
What This Means in Practice
- ISO 14971: Structured hazard → situation → harm mapping, residual risk tracking, and post-market updates
- IEC 62304: Software versions tied directly to risk files, with complete audit logs
- FDA Good Machine Learning Practice (GMLP): FDA-only reference data, clear AI labeling, and mandatory human approval
- FDA Clinical Decision Support Guidance: Explainable recommendations with editable rationale and citations
- AI Governance (ISO/IEC 23894 & 42001): Transparent AI usage, role-based approvals, and full traceability
Get Started with Cira Health
Experience AI-powered risk management for MedTech. Fill out the form below to request a demo or start your free trial.
Cira Health for Smarter, Faster,
Compliant Risk Management
Cira Health helps medical device teams work faster without sacrificing compliance, maintain clear, defensible traceability, and turn risk management into a living, proactive process, all while fitting seamlessly into how you already work.