Medical Devices
Get Your Device Cleared Faster Without Regulatory Guesswork
Assyro AI helps medical device companies navigate 510(k), PMA, De Novo, and global device submissions. From pre-submission preparation to post-market surveillance, our AI platform covers the complete device regulatory lifecycle.
Challenges We Solve
- Determining the right regulatory pathway (510(k) vs PMA vs De Novo) wastes weeks of analysis
- Substantial equivalence documentation for 510(k)s is assembled manually with no traceability
- EU MDR/IVDR implementation timelines keep shifting and requirements are hard to track
- Global device registrations require coordinating across 10+ markets simultaneously
- Technical file maintenance and design history documentation falls behind between submissions
How Assyro AI Helps
- Prepare 510(k), PMA, and De Novo submissions with AI-guided pathway selection
- Generate predicate device comparisons and substantial equivalence arguments automatically
- Track EU MDR/IVDR requirements and notified body expectations in real time
- Manage global device registrations across all target markets from one dashboard
- Monitor FDA warning letters and enforcement actions relevant to your device class
Regulations We Cover
Solutions by Role
Explore how Assyro AI helps specific teams within medical device companies.
Regulatory Affairs
RA professionals spend 60% of their time on manual drafting, formatting, and regulatory tracking instead of strategic work. Assyro automates the grind so you focus on the decisions that actually move submissions forward.
Quality/QA
Assyro AI helps quality assurance professionals maintain GxP compliance, track regulatory inspections, and ensure documentation integrity. Stay audit-ready and proactively address quality issues with AI-powered intelligence.
Clinical
Assyro AI supports clinical development professionals with regulatory intelligence for trial design, IND submissions, and global clinical requirements. Navigate the regulatory landscape confidently from Phase 1 to NDA.
Frequently Asked Questions
Assyro identifies predicate devices, generates substantial equivalence comparisons, validates eSTAR formatting, and checks all required sections for completeness. AI drafts key sections based on your device specifications.
Yes. Assyro analyzes your device characteristics and intended use to recommend the appropriate regulatory pathway, factoring in FDA guidance, predicate history, and risk classification.
Yes. Comprehensive EU MDR support including Annex requirements, technical documentation guidance, UDI compliance, and post-market surveillance requirements with the latest notified body expectations.
Assyro covers SaMD-specific requirements including IEC 62304 compliance, clinical evaluation, cybersecurity documentation, and the evolving digital health regulatory landscape.
Ready to Transform Regulatory Operations?
See how Assyro AI can accelerate submissions and ensure compliance for your medical devices team.
Schedule a Demo