Medical Device Documentation
Document medical device manufacturing, testing, and deployment with cryptographic proof. Verified evidence for FDA submissions, field safety notices, and post-market surveillance.
The Problem
FDA Submission Rejections
Device submissions rejected due to insufficient evidence of testing and manufacturing conditions.
Product Liability
Device failures lead to litigation. Manufacturers need verifiable proof of proper manufacturing and testing.
Field Failures
Post-market device failures require investigation. No verified record of deployment conditions.
How Immutis Helps
Hardware-backed cryptographic proof integrated into your existing workflow.
Manufacturing Evidence
Document device manufacturing and testing with hardware-attested proof. FDA-submission ready.
Field Surveillance
Post-market device monitoring with verified evidence. Rapid response to safety issues.
Deployment Records
Installation conditions documented with proof. Field failures traceable to verified baseline.
Key Features
UDI Integration
Tie captures to unique device identifiers
FDA Ready
Documentation format meets submission requirements
Field Verification
Verify device installation conditions
SDK Integration
Drop into existing systems
Compliance
Meets industry standards and regulatory requirements
Ready to verify every capture?
Start your pilot program and see the difference cryptographic proof makes.
Start Device Pilot