Stop managing the pieces. Start building the work.
QualiVerse® Maestro is QMB's regulatory operating system, purpose-built to deliver regulated lifecycle intelligence across MedTech product development. It sits on top of the eQMS, PLM, and validation systems you already run, and does the regulatory work itself instead of tracking it.
Bring one of your files. See how QualiVerse holds up against it.
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THE OLD PARADIGM
The old paradigm
Every stack, tracked separately
Classification, evidence, risk, and traceability each live in a different system.
No shared record
Nothing connects one system's view of the file to another's.
Held together by hand
Someone still has to reconcile all of it before it becomes one file.
Faster object management is still object management
A quicker way to file, tag, and retrieve the same fragmented pieces does not change what the work actually is.
QualiVerse builds the work itself, not a faster shelf to keep it on.
QualiVerse® Maestro
RegWise decides what must be proven: strategy, pathways, and evidence requirements. Smart Vault creates the connected work itself, not a repository. AssureCheck assures the evidence and the work hold together, before a reviewer has to ask. NavIQ learns from changes and gaps to determine what matters next. Decide, create, assure, learn, and repeat: four modules, one system.
The intelligent lifecycle is the product
An AI-enabled ALM is judged on speed of automation, and generally on how the output looks. QualiVerse is judged on whether the evidence embedded in the lifecycle, or the narrative behind that output, survives a reviewer: the same inputs produce the same result, every step traces to the person who approved it, and nothing ships without expert sign-off.
Results, not architecture
A populated artifact. Not a template. An Evidence Generated Artifact filled in against your actual device.
A live traceability matrix. Design inputs, outputs, and risk controls linked and current, not rebuilt at review time.
The artifact is the interface
Every artifact renders in the structure a reviewer already expects, so nothing about it needs translating.
Deterministic and traceable
Every output resolves the same way from the same inputs, and every claim in it traces back to the evidence behind it. That is the standard the artifact is held to.
USE CASES
Start wherever the work already is
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Regulatory Strategy & Pathway
RegWise maps classification, product code, and predicate candidates into a defensible pathway, with a regulatory strategy summary and predicate analysis ready to hand a reviewer.
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Design & Risk Evidence
Smart Vault connects the Design Traceability Matrix and Risk Analysis Report back to the Product Requirements Specification, so every design decision carries its evidence.
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Expanding
Submission Readiness
AssureCheck reviews the full DHF and RMF for completeness and consistency before a reviewer ever opens the file, flagging gaps while there's still time to close them.
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Expanding
Audit Trail
NavIQ traces a proposed change back through every affected requirement, producing a documented impact assessment with the regulatory rationale attached.
Learn moreTHE BOUNDARY
QualiVerse doesn't replace the systems you already run
QualiVerse does not administer the regulated lifecycle. It provides the intelligence that determines what the lifecycle requires.
Where the requirements, evidence, and context live
RIMS, eQMS, PLM and ALM, clinical systems, and ERP/MES each hold a piece of the picture.
RegWise
Determines what must be proven: strategy, pathways, evidence requirements, standards, and regulatory reasoning.
Smart Vault
Turns evidence and decisions into finished regulated work, not generic document control or a repository.
AssureCheck
Confirms the evidence and the work hold together: completeness, consistency, traceability, and assurance.
NavIQ
Reasons across changes, gaps, and impact to determine what matters next.
Decisions, artifacts, and assurance
Strategy, DHF, RMF, CER, submissions, change assessment, and traceability, finished and defensible.
THE HUMAN DIFFERENCE
Software should adapt to the expert
Not the other way around.
You work in your format
Your existing templates, review cycles, and file structure stay exactly as they are.
QualiVerse fits inside it
The platform drafts and updates within the systems and formats your team already uses.
Human Judgment by Design
QualiVerse was built for regulatory professionals, with workflows that allow experts to review, challenge, refine, and redirect the analysis at every stage. It strengthens regulatory decision-making without replacing the expertise behind it. For teams without dedicated regulatory professionals, QMB expert support hours can be added to provide experienced regulatory guidance when needed.
THE COMPARISON
Two ways to run the same work
Assembly
Assembled and reconciled by hand Runs inside the platform
Gaps
Surface at review, when they are costly Surface during the build, when they are cheap
Rationale
Reconstructed months later Captured at the decision
Every next submission
Starts close to zero Starts from the last one
Move at the Speed of Innovation
Confident. Compliant. Complete.
See QualiVerse® in Action