PCCP compliance monitoring, automated.
Be the AI vendor hospitals trust.
Sentir reads your authorized PCCP, runs the monitoring it requires, and generates audit-ready compliance documentation automatically. Your regulatory team reviews and approves. That's it.
Or request a product brief by email.
HIPAA-aligned architecture·AWS US-East-1·No PHI stored·AES-256 encryption·BAA on request
The monitoring obligation is real.
Health systems are increasingly requiring post-market surveillance documentation before signing AI vendor contracts. Most cleared vendors don't have audit-ready documentation mapped to their specific regulatory commitments.
Only 9% of FDA-cleared AI devices have a post-market surveillance plan.
How Sentir works
We read your PCCP
Upload your authorized PCCP. Sentir extracts every monitoring commitment — drift thresholds, subpopulations, cadence, metrics.
We run the monitoring
Integrate in minutes. Sentir logs your production predictions and runs automated drift detection against your specific PCCP commitments every week.
We generate the report
Every quarter, a compliance evidence report mapped to your PCCP sections lands in your inbox. Your regulatory team reviews and approves.
What lands in your inbox
Every quarter, mapped to your PCCP sections. An excerpt:
Sample excerpt. Real reports include your device's full PCCP section mapping, statistical evidence, and audit trail.
Built for FDA-cleared AI/SaMD vendors
Vendors with authorized PCCPs
Satisfy your monitoring commitments automatically. Never scramble when someone asks for documentation.
Vendors preparing PCCP submissions
We help write your monitoring section, then deliver the infrastructure that satisfies it post-clearance.
Radiology AI, diagnostic AI, clinical decision support
The most actively updated AI medical devices need the most systematic monitoring infrastructure.
Already tracking metrics internally? Engineering dashboards show you what's happening. Sentir generates the audit-ready documentation that proves it to someone outside your team.
Ready to satisfy your PCCP commitments?
Talk to us before your next hospital contract renewal or FDA audit.
Or request a product brief by email.