Focused FDA Mock Review Module

FDA Risk Management Mock Deficiency Review

For medical devices across all submission pathways, Panabistics reviews the risk management file against FDA expectations and produces a mock deficiency letter identifying likely review questions before submission.

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Risk Management Module

Risk Management Mock Deficiency Review

The review focuses on whether the risk management file is complete, credible, traceable, and consistent with the device design, verification and validation evidence, labeling, clinical and performance data, and eSTAR content.

Review Scope

Risk Management Review Scope

Area Reviewed	What We Assess
Risk management plan	Whether the risk management plan defines scope, responsibilities, criteria, and activities appropriate to the device and submission.
Hazard analysis	Whether hazards, hazardous situations, and harm are identified comprehensively and supported by the device description.
Risk controls	Whether risk control measures are appropriate, implemented, verified, and traceable to identified risks.
Residual risk	Whether residual risks are evaluated, disclosed, and acceptable in the context of device intended use.
Benefit-risk	Whether benefit-risk considerations are credible and supported by clinical, performance, and labeling evidence.
Traceability to V&V and labeling	Whether risk controls are linked to verification, validation, and labeling content throughout the submission.
ISO 14971 alignment	Whether the risk management process and file align with ISO 14971 expectations and FDA guidance.
eSTAR consistency	Whether risk management content aligns with software, cybersecurity, labeling, test evidence, and system description.

Deliverables

Risk Management Mock Review Deliverables

Mock FDA Risk Management Deficiency Letter

FDA-style questions and deficiencies focused on likely risk management review concerns.

Risk Management Deficiency Register

Excel-style tracker with issue, source, severity, regulatory basis, recommended fix, and owner field.

Executive Readiness Memo

Clear readiness summary with go, conditional-go, or not-ready recommendation.

Remediation Roadmap

Prioritized steps to strengthen the risk management file before submission.

Optional Remediation Support

Support to revise documents, address gaps, and prepare stronger FDA-facing risk management evidence.

Audience

Who Should Consider This Review

FDA 510(k) submissions with risk management files
FDA De Novo submissions with risk management files
eSTAR submissions with risk management content
Novel or higher-risk device submissions
Submissions with complex hazard profiles
Risk files after internal or external audit
Responses to FDA risk management questions
Final submission readiness checks before filing

What This Service Is Not

This service does not replace FDA review, risk analysis activities, design controls, legal advice, or the sponsor’s responsibility for submission content. It is an independent regulatory and submission-readiness review designed to identify likely FDA review concerns before submission. Panabistics does not represent FDA and does not guarantee clearance or approval.

Available Independently or as Part of the Full eSTAR Review

This focused module can be commissioned independently or included as an applicable component of a broader Full eSTAR Mock Deficiency Review when the substantially complete submission package is available.

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Full eSTAR Mock Review Cybersecurity Software Documentation Human Factors & Usability Labeling & Claims Bench & Performance Clinical Evidence

Request a Review

Request a Risk Management Mock Deficiency Review

Tell us about your device, submission pathway, and risk management file. We will respond within 24 business hours.

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