REGULATED LIFECYCLE INTELLIGENCE FOR MEDTECH
Confidence at the Speed of Innovation.
QualiVerse® Maestro turns regulatory requirements, product evidence and expert judgment into the finished, defensible work required to bring and keep medical devices on the market.
Confident. Compliant. Complete.
Trusted by regulatory and quality teams across MedTech
ISO/IEC 27001 certified
Information security management.
ISO 13485 certified
Medical-device quality management system.
Looking complete is not the same as being defensible
A file can read as thorough and still fail the moment a reviewer tests it.
Every Evidence Generated Artifact resolves to the requirement it answers and the evidence behind it, so completeness is checked the way a reviewer checks it, not assumed from a table of contents. QualiVerse treats defensibility as the standard to build to, not a quality to claim afterward.
Two records can look identical from the outside. One has the requirement defined, the criteria measurable, and the evidence sufficient. The other does not, and only shows it when a reviewer opens the file. The first is defensible engineering. The second is regulatory theater.
Defensibility is built from the roots up
Roots: the evidence base. A proprietary knowledge graph of regulatory sources, guidance, and precedent grounds every output in reviewed evidence, not general web training.
Trunk: expert judgment. Seasoned regulatory professionals review and refine every Evidence Generated Artifact, carrying a defensible chain of judgment through the file.
Canopy: the submission-ready package. What reaches reviewers is the visible result: a complete, compliant, defensible package built to clear review.
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.
PRODUCT PROOF
What QualiVerse produces
Every Evidence Generated Artifact traces back to the requirement it answers. IP placeholders are flagged for your team, and nothing reaches a reviewer without expert review first.
Predicate device identification, side-by-side comparison, and gaps in supporting evidence flagged automatically, before they become a reviewer's question.
- Regulatory strategy generated automatically
- Predicate candidates ranked by match
- Gaps flagged before submission
A Design History File and Risk Management File, with a live traceability matrix: every requirement traced to its supporting evidence and risk control.
- Design Traceability Matrix, live
- Every document status tracked
- Requirement linked to supporting evidence
USE CASES
Start wherever the work already is
Regulatory Strategy & Pathway
Classification, product code, predicates, pathway, requirements, and roadmap.
Learn moreDesign & Risk Evidence
Turn requirements and evidence into connected design-control and risk work.
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THE 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.
Human Judgment by Design
Judgment stays where it belongs.
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.
From Scientific Hypothesis to Regulated Product Architecture in <6 Months
QualiVerse turned an early biomaterials hypothesis into a regulated, submission-ready product architecture in under six months, one of three case studies across MedTech, biomaterials, and AI-enabled SaMD.
Move at the Speed of Innovation
Confident. Compliant. Complete.
See QualiVerse® in Action