Reviewer

Expert gap assessment agent for FDA, MDR and IVDR submissions and QMS compliance

FDA, MDR and IVDR submission reviews

Reviewer supports you from design freeze to approved submission with expert gap analysis reviews that ensure you identify gaps earlier and empower your team to progress much faster without needing external expertise at every step.

AI enabled data ingestion

Seamlessly load, review and export your submission documentation

Load existing eStar FDA PDF
Auto-fill FDA eStar and MDR / IVDR submission fom unstructured documents
Export to FDA eStar PDF

Expert gap analysis

Get comprehensive gap analysis on your draft submission in minutes

Immediately see where there are potential gaps and severity
Gap analysis is grounded with clear sources, showing you both why and where the gaps are
Provides Expert recommendation for how to fix gaps or improve documentation clarity

Expert submission Q&A

Get expert answers to complex questions

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QMS compliance and adherence reviews

Reviewer provides expert gap analysis to make sure your QMS is audit ready, weather for initial certification or survevillance audit. The expert Q&A allows you to semlessly plan QMS changes or adddress auditor quesitons.

AI audit

Get in-depth audit of you quality manual, procedures and forms

Simply load your Quality Manual, proccedures and forms. Reviewer will automatically recognize each document.
Get detailed compliance review against ISO 13484, EU MDR/IVDR and FDA QMSR requirements in minutes
Grounded analysis points out clear rationale, sources and steps to close each gap

AI enabled change management

Expert Q&A guides you for QMS changes or questions from auditors

Get exper answers to any question about your QMS
Guides your team for how to implement changes or address questions from auditors
Grounded responses based on your procedures& records and ISO 13485, MDR and QMSR requirements