Medical Device Regulatory Submission Software
Coordinate 510(k), De Novo, predicate, and evidence workflows in one regulatory workspace. Keep testing, labeling, and filing decisions aligned before package lock.
Medical Devices Submission Workflow
See where Medical Devices teams lose time across drafting, review, validation, and partner coordination.
Build 510(k) Packages That Pass Acceptance Review
90% of first-submission 510(k) packages get an RTA notice. Assyro validates against FDA's Acceptance Review checklist continuously so the submission passes on first review and moves directly to substantive review.
Run Predicate Analysis in Hours, Not Weeks
Full-text search across 200,000+ cleared devices, side-by-side SE comparison tables, and flagged SE gaps. Predicate strategy that took a week of database triage and Word tables now takes an afternoon.
Coordinate Engineering, QA, and RA in One eSTAR
Engineering drafts verification sections, QA handles risk management, RA owns predicate logic — all concurrently in the same workspace. No more RA waiting on engineering to email the latest test report.
Catch the Labeling-to-Indications Mismatch Before FDA Does
The most common 510(k) RTA trigger is inconsistency between the indications for use, device description, and labeling. Assyro's cross-section consistency checks surface these mismatches during drafting, not during FDA review.
Medical Devices Workflow Controls at Scale
Keep submission growth controlled with clearer ownership, better traceability, and consistent execution across active programs.
Maintain Audit-Ready Submission Workflows
21 CFR Part 820, EU MDR 2017/745, EU IVDR 2017/746 aligned workflows with audit trails, role-based access, and submission traceability.
Manage More Medical Devices Programs With the Same Team Size
Monitor FDA warning letters and enforcement actions relevant to your device class
Questions About Medical Devices Workflows
Practical questions buyers ask when evaluating medical device regulatory submission software.
