Reviewer

Expert-level review that gets you approval-ready and keeps you compliant seamlessly

✓ FDA

✓ MDR

✓ IVDR

✓ QMS

Reviewer uses agentic, multi-step reasoning to evaluate submissions (FDA, MDR, IVDR) and QMS documents against relevant regulations and guidelines. It identifies gaps, inconsistencies and missing evidence, and suggests concrete actions before anything is sent to authorities or partners.

You provide draft submission or QMS documentation. Reviewer evaluates them against applicable regulatory requirements to get you approval-ready and remain compliant.

Key Features

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Comprehensive reviewer agent

Dedicated reviewer agent for in-depth evaluations covering all sections of a FDA, MDR or IVDR submission and QMS compliance

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Requirement-based evaluation

Requirement based evaluation using comprehensive regulatory knowledge base.

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Content gap identification

Gap identification for missing, incomplete, or inconsistent content across documents.

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Evidence-backed structured outputs

Structured outputs backed by regulatory evidence for internal review and audit.

Get a structured list of issues to address rather than staying with a vague sense that something is missing.

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Select from a comprehensive set of reviews for FDA, MDR and ISO compliance

Import existing FDA eStar or unstructured files with auto-classify
Review submission documents for consistency and content compliance to FDA, MDR & IVDR requriements
Export back to FDA eStar format or Word document

Comprehensivev AI reviews with expert reasoning and grounded compliance checks

Triage of issues by severity
In depth rationale for each potential non-compliance
Grounded on reference regulatory documents with clear links to sources for each finding
Actionable recommendations for how to close gaps.