Find it in the documents, not the field.

Machine-speed analysis of technical specifications. Find contradictions, gaps, and duplicates before sign-off.

Medical device requirements & compliance analysis

Design is the
single leading cause of device recalls.

The most common root cause the FDA records for a recall is device design, ahead of manufacturing and labeling. Most of it traces back to a specification baseline no single reviewer could hold in working memory at once. Wyzer Detective reads that whole set together, design inputs alongside risk controls and verification criteria, for the contradiction and the gap a section-scoped design review does not catch.

13%
Device design is the single leading root cause across 58,374 FDA recalls analysed1
21%
Share of Class I (most serious) FDA recalls rooted in design issues2
50%
Recalls of AI/ML-enabled devices traced to design or software-design factors3
$525M
Potential cost of a single major Class I recall — litigation and response included4
1 MedDeviceGuide analysis of the FDA device recall database: device design is the leading identified root cause at 13.0% across 58,374 recalls.2 U.S. GAO, "Medical Devices: FDA Should Enhance Its Oversight of Recalls" (GAO-11-468): FDA data show device design accounted for 14% of all recalls and 21% of Class I recalls.3 JMIR Medical Informatics, "Regulatory Insights From 27 Years of AI/ML-Enabled Medical Device Recalls" (2025): design- and software-design-related factors account for roughly 50% of recalls in this device class.4 Lumafield, "The Real Cost of a Product Recall and How to Prevent One": a single major Class I recall can cost a manufacturer up to $525M in litigation, regulatory response, and reputational damage.

Where Wyzer Detective fits

Applied to the healthcare requirements you already write, in the review step you already run.

Design input contradiction detection

Checks user needs, design inputs and design outputs against each other for the conflicting requirement a section-scoped design review does not catch. FDA data ties that class of defect to the largest share of recalls.

Risk-control traceability gaps

Flags ISO 14971 risk controls with no corresponding design requirement, and design requirements with no traceable hazard. It is the first thing a notified body asks about at audit.

IEC 62304 completeness checks

Software requirements scored for the ambiguity and missing acceptance criteria a Class B or C software safety classification cannot tolerate.

Duplicate and near-duplicate detection

Requirement sets that accumulate across design history files and submission amendments often restate the same requirement with small wording drift. Wyzer finds where that drift has quietly created two different requirements instead of one.

Standards & frameworks

Wyzer Detective doesn’t replace the process — it checks the requirement set the process depends on.

IEC 62304 (Software Lifecycle)ISO 13485ISO 14971 (Risk Management)FDA 21 CFR 820EU MDR

A representative example

A Class II device design history file with several hundred design inputs and a matching risk file of hazard-derived controls. The mechanical, electrical and software teams each review their own inputs against their own risk controls. Nobody checks a mechanical design input against an electrical risk control that assumes a different tolerance for the same interface. That is the conflict Wyzer Detective is reading for, across the whole design input and risk-control set, at every revision.

The example above illustrates the class of defect Wyzer Detective catches — it is not a specific customer engagement.

Frequently asked questions

See it on your own specification

Export a ReqIF baseline and get a full Wyzer Detective analysis — quality scores, contradictions, and coverage gaps — within minutes.

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