Find it in the files, not the field.
Machine-speed analysis of technical specifications. Find contradictions, gaps, and duplicates before sign-off.
Find it in the files, not the field.
Machine-speed analysis of technical specifications. Find contradictions, gaps, and duplicates before sign-off.
Medical device requirements & compliance analysis
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.
Applied to the healthcare requirements you already write, in the review step you already run.
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.
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.
Software requirements scored for the ambiguity and missing acceptance criteria a Class B or C software safety classification cannot tolerate.
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.
Wyzer Detective doesn’t replace the process. It checks the requirement set the process depends on.
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.
Yes. Wyzer flags risk controls with no traceable design requirement, and design requirements with no traceable hazard, so the gap surfaces before an audit does.
Yes, via ReqIF. If your design history file lives in Word, Excel, or PDF-style documents instead, Wyzer partners with specification-standardization providers who convert those into clean ReqIF input first.
Same day. Export a ReqIF baseline, upload it, and Sherlock returns quality scores, contradictions, and coverage gaps within minutes. No configuration, no training data, no integration project.
No. Customer data is not used to train the system and is not exposed to other customers or external models. Data is encrypted at rest.
In the EU. Wyzer's infrastructure runs in an EU region, isolated to your environment, with standard retention capped at 90 days by default.
No practical one. Sherlock has been tested to tens of thousands of requirements with no degradation in output quality: it processes specifications in parallel batches rather than reading them end to end.
No. Reviewers keep working in the requirements tool they already use. Wyzer Detective runs before or alongside the existing review, and relevant findings get applied back into that review. It's a quality-gate step, not a new system to adopt.
Credit-based pricing that scales with the number of requirements in your specification and how complex they are (plain text vs. requirements with tables or diagrams). There's no fixed per-seat licence. Get in touch for a quote sized to your specification. Searching a finished analysis with a defect or failure description (the Requirement Scan API, in beta) costs one credit per query, whatever the size of the specification.
Yes. Any ReqIF export works as the reference: a published standard, an internal template, last year's baseline, whatever you want the current spec measured against. The comparison runs requirement by requirement, not as a single aggregate score, so you can see exactly which ones fall short.
Export a ReqIF baseline and get a full Wyzer Detective analysis within minutes: quality scores, contradictions, and coverage gaps.
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