The AI Compliance & Quality OS

Prove your
Every product, every market, every day.

Qurelio is the AI-powered compliance platform that turns your product files and each market’s public laws into audit-ready proof. The Product Vault, Laws & Regulations Portal, Compliance Engine and Regulatory Monitoring Hub work as one, so you enter new markets faster and stay ahead of every change.

  • Public laws only
  • Every AI result approved by you
  • French and English

Why Qurelio

What makes Qurelio the intelligent compliance platform

Built from the ground up for quality teams who need more than spreadsheets. Qurelio combines AI, automation, and deep regulatory intelligence into one unified platform. And because compliance is too important to leave to a machine, every AI result waits for your approval before it becomes real.

100% legal by design. Qurelio works exclusively with public, legally free regulatory texts: laws, decrees and official regulations. Licensed standards such as ISO/IEC are automatically detected and are never stored or analyzed.

AI-powered

Stay audit-ready, every day of the year

Explore the Compliance Engine

Cut compliance prep by 70%

Continuous AI assessment of your products against the public laws, decrees and regulations of your target markets, turning a 3-month exercise into a same-day, repeatable check.

Actionable, not abstract

Every gap comes with a plain-language explanation, a recommended fix, an owner, and a deadline. No more 80-page audit reports nobody opens.

You stay in control

Every AI-generated result (reports, action plans, detected gaps) lands in a review queue first. Nothing becomes an official record or an executable action until your Quality Manager approves it.

How it works

How it works

Three calm steps. From the day you describe your organization to the daily rhythm of staying compliant, Qurelio guides every move, and you approve every decision.

01Onboard

Teach Qurelio your organization

Start where you are.

Describe your company, products and markets, then bring your product folders and quality documents into one organised home. Qurelio builds a private compliance memory of your organization, so every answer is about your reality.

  • Guided onboarding captures your activity, markets and quality context
  • Drag-and-drop bulk import of product folders and records
  • Private by default: your memory is yours alone, never shared
02Assess

Upload a regulation, get your verdict

See the gaps clearly.

Add any public law, decree or regulation that applies to you. Qurelio evaluates your products against it, clause by clause, and returns a compliance score and maturity level, with every gap explained in plain language.

  • Clause-by-clause compliance and maturity assessment
  • Plain-language explanation of every gap
  • Suggested fixes, each with an owner and a date, pending your approval
03Monitor & improve

Never be surprised by a regulation again

Keep the momentum.

Qurelio keeps watching. When a regulation changes, or a relevant one you never mentioned appears, you get an alert that says exactly which products are affected and what to do. Every closed gap becomes a visible milestone.

  • Alerts when regulatory changes affect your compliance
  • Detection of applicable regulations you didn’t know about
  • Live KPIs and a one-click evidence trail, ready for any auditor

Plans and pricing

The same engine in every plan, sized to your portfolio

Choose the plan that fits your regulatory complexity. The legal guardrail, the human-in-the-loop quarantine and the audit trail are in every plan — what scales is your portfolio, not your safety.

Request pricing

Annual contracts. No implementation fee and no per-module add-ons for core quality operations. Talk to us for a quote.

Early access

Early Access Pilot

Professional, in full, at pilot pricing — shape the product with us.

5 users · Professional scope otherwise · open worldwide
  • The complete Professional plan — no feature exceptions
  • Dedicated onboarding session, no charge
  • Priority addition of your regulatory sources to the monitored registry
  • Direct feedback line to the product team + roadmap input
  • Custom scope available after pilot
  • Standard Professional pricing applies from client 6 onward
Request pilot access

contact@qurelio.com · open worldwide

Starter

Run quality operations properly, and get your first regulations under control.

3 users · 3 products · 2 active regulations
  • Onboarding wizard & organizational profile
  • Product Vault — folder ingestion → private Compliance Memory
  • Compliance Engine — obligations, gap list, weighted score, every finding cited
  • Legal Guardrail & HITL Quarantine on every AI output
  • File Library, Non-Conformities & CAPA lifecycle
  • Internal audits, root-cause tools, action plans
  • Email support, 48h · assisted onboarding included
Start free trial

14-day trial · no credit card

Enterprise

Multi-site, multi-supplier, configured to your quality system.

Unlimited users, products & regulations · multi-site consolidation
  • Everything in Professional
  • Supplier Quality Management — AVL, scorecards, risk tiering, SCAR
  • External Supplier Portal with isolated access
  • Multi-site portfolio — consolidated and per-site scoring
  • Configurable scoring, custom roles & external auditor access
  • SSO (Google, Microsoft, SAML 2.0) · public API & webhooks
  • Dedicated Customer Success Manager + contractual SLA
Request a quote

tailored scope

Compare

Every feature, every plan

Organised by the five pillars of the platform. Scroll horizontally on smaller screens.

included not included
What is includedEarly AccessStarterProfessionalEnterprise
Scope
Users5 · worldwide310Unlimited
Products in the Product Vault25325Unlimited
Active regulationsUnlimited2UnlimitedUnlimited
AI evaluation runs / yearFair use4Fair useUnlimited
Sites / legal entities313Unlimited
Pillar 1 — Context & Memory
Onboarding wizard & organizational profile
Product Vault — folder ingestion → Compliance Memory
Product Vault registry & regulatory profile
OCR & text extraction
Pillar 2 — Compliance Engine
Laws & Regulations Portal — public-regulation upload & analysis
Obligation extraction, cited to the source passage
Obligations Register + liability acceptance
Gap list & evidence mapping
Compliance score (criticality-weighted)Configurable
5-level maturity modelConfigurable
Confidence indicators on every AI output
Re-evaluation & score history+ automaticOn demand+ automatic+ automatic
AI-suggested NCs & CAPAs from gaps
Pillar 3 — Regulatory Monitoring Hub
Monitored source registry—
Scheduled change detection (cosmetic changes filtered)—
Impact analysis on your obligations & scores—
Missing-regulation detection—
Severity-based alerts—
Pillar 4 — Quality Operations
File Library — versioning, approval, ACL, search
Non-Conformities
CAPA lifecycle & effectiveness verification
Internal audits, checklists, findings → NC
Root-cause: 5-Whys · Ishikawa
Root-cause: 8D—
Action Plan Center · Kanban · calendar
Training portal & competency matrix
Supplier Quality — AVL, scorecards, SCAR———
External Supplier Portal———
Management Review · Change Control · Calibration · CSAT · HSE———
Pillar 5 — Intelligence & Control
Legal Guardrail — pre-upload liability consent
Legal Guardrail — licensed-standard detection & block
HITL Quarantine on every AI output
AI disclosure label on every AI output
Quarantine inbox & transition history
Qurelio AI Assistant (cited, tenant-scoped)—
Dashboard & KPIsFull + heatmapStandardFull + heatmapFull + consolidated
Audit-readiness score—
Drill-down & date filtering—
Reporting & export
PDF scorecard—+ branded
Excel / PowerPoint export—+ branded
Audit-Readiness Dossier—
Platform & security
Roles535Custom
Scoped External Auditor access———
SSO — Google · Microsoft · SAML———
Tenant data isolation
Append-only audit trail
Audit-log export & retention configuration———
Public API & webhooks———
Interface languagesFR · ENFR · ENFR · ENFR · EN
Support & onboarding
OnboardingDedicatedSelf-service2 sessionsFull programme
SupportPriority emailEmail · 48hEmail + chatCSM + SLA
TrialNegotiated14 days14 days30-day POC

Scroll the table sideways to see every plan →

Scale & billing

You only pay for what you monitor

Every plan extends along the four dimensions that actually grow with your portfolio: users, products, regulations and evaluation runs.

Add-ons

Added at any time, prorated to your current billing period. Rates are part of your quote.

Add-onStarterProfessionalEnterprise
Additional userAvailableAvailableAvailable
Products — pack of 10AvailableAvailableIncluded
Active regulations — pack of 5AvailableIncludedIncluded
Additional site / legal entity—AvailableIncluded
AI evaluation runs — pack of 10AvailableFair useIncluded
Supplier Portal seats — pack of 25——Available

Billing

Invoices issued in EUR.

Standard
Annual, billed once per year.
Quarterly
Available on Starter and Professional; terms in your quote.
Semi-annual
Enterprise, on request.
Implementation
None. Onboarding is included in every plan at no extra charge.
Contract
Minimum 12 months. Auto-renews unless cancelled 30 days before the renewal date.
Changes
Upgrade any time, prorated. Downgrades take effect at renewal.

Questions

What RA & QA teams ask us first

Qurelio ingests only public, freely reusable legal texts. Every regulation in your workspace displays its source URL and its legal status, so you can verify it yourself at any time. Licensed standards — ISO, IEC and equivalents — are automatically detected on upload and are never stored, never embedded, and never sent to an AI model. That is enforced by the platform’s architecture, not by policy. Where a standard you need is licensed, Qurelio tells you which one to acquire and lets you work from your own copy.

Every AI output carries a visible AI disclosure and is created in Quarantine. Nothing an AI produces becomes executable until your Quality Manager reviews it and accepts it — with edit, accept and reject controls and a full transition history of who accepted what, and when. Qurelio never makes an autonomous compliance decision, and every finding cites the passage of the source text it came from.

The AI helps you work faster. You remain responsible. That is exactly what your auditors expect.

Your data is isolated in a dedicated tenant environment — no other Qurelio client can reach your products, regulatory profiles, gap analyses or audit records. We sign a Data Processing Agreement before any data enters the system, and the audit trail is append-only. Your documents are never used to train a model.

Because it is the reason to use Qurelio. Plans differ by how much you run through it — how many products, regulations and evaluation runs — not by whether you get it at all. A Starter customer analyses two regulations against three products; an Enterprise customer runs an entire multi-site portfolio. Same engine, same guardrails, same audit trail.

Yes. Upgrade at any time — the difference is prorated from your current billing period. Downgrades take effect at the next renewal date. Enterprise clients should speak to their Customer Success Manager directly.

Starter and Professional include a 14-day free trial, no credit card required. Enterprise clients receive a 30-day proof of concept built around their own regulatory context and product portfolio.

Onboarding is included in every plan at no extra charge — we assist every client personally, regardless of plan. We do not charge implementation fees.

An early-access programme open worldwide — the first five manufacturers to join, from any country. Pilot clients get the complete Professional plan at pilot pricing, with priority for adding their national regulatory sources to the monitored registry — each source subject to legal clearance before it goes live. The interface is FR/EN today; Arabic is on the roadmap. Standard Professional pricing applies from client 6 onward. After the pilot, scope can be customised — users, modules, and regulations adapted to your exact quality system. Write to contact@qurelio.com to apply.

Yes — and that is the point of the pilot. After your onboarding period, Early Access clients and Enterprise clients can adjust scope with us: the number of users, the modules active in their workspace, the regulatory sources being monitored, and the add-on dimensions (products, regulations, evaluation runs). We scope the arrangement to your actual quality system — not to a fixed tier. Contact your onboarding contact or write to contact@qurelio.com to discuss.

Next step

Not sure which plan fits? Let’s scope it together.

Tell us your products, markets and regulations. We walk you through Qurelio on your own context and send a quote that matches.

  • 14-day free trialStarter and Professional, no credit card.
  • 30-day proof of conceptEnterprise, built around your own portfolio.
  • Onboarding includedEvery plan, no implementation fee.

Industries · Medical devices

From the technical file to post-market follow-up

Qurelio reads your device documentation, sets it against the public regulations of the markets you sell in, and shows what is covered, what is missing and what just changed.

Public texts by market

European Union

EU MDRMDCG guidanceMDD / AIMDD (legacy)

United States

QMSR (21 CFR 820)21 CFR 80321 CFR 807 · 510(k)21 CFR 814 · PMA21 CFR 812 · IDE21 CFR 80121 CFR 830 · UDI

International

IMDRFMDSAP

The daily reality

Where device teams lose time

Today

  • One file, several marketsThe same device has to satisfy European, American and national rules, each with its own structure and vocabulary.
  • Evidence scattered across foldersRisk files, labelling, clinical and test reports live in different places, so answering one auditor question takes days.
  • Changes found too lateA guidance update or an amended article is noticed during the audit, not when it was published.

With Qurelio

  • One file, read against each marketThe same product folder is assessed against each regulation you add, without entering anything twice.
  • Evidence linked to each obligationEvery obligation points to the documents that answer it, so an auditor question is answered in minutes.
  • Changes flagged when publishedThe Regulatory Monitoring Hub alerts you to changes of substance and names the products affected.

How Qurelio fits

Your device, checked against the law that applies to it

Four engines, used in this order. Every AI result waits in Quarantine until your Quality Manager accepts it.

Product VaultUpload the product folder once. Qurelio reads it and builds a private Compliance Memory for that product.
Laws & Regulations PortalAdd the public texts that apply to your markets. Each one shows its source and its legal status.
Compliance EngineGet the obligations, a gap list and a weighted score, with every finding cited to the passage it comes from. Regulatory Monitoring HubBe alerted when a text changes in substance, and see which products and scores it touches.

Regulatory scope

What you can work from

Public texts Qurelio can analyse

Laws, regulations and official guidance that are free to reuse. You add them in the Laws & Regulations Portal and the Compliance Engine reads them in full.

Licensed standards, referenced only

Qurelio records the number and scope so your file stays complete. The text itself is never stored or analysed: you work from the copy you purchased.

ISO 13485ISO 14971ISO 10993IEC 60601-1IEC 62304IEC 62366-1ISO 15223-1ISO 11607ISO 14155

National texts for your own markets are added by you under your liability consent, then checked for legal clearance before they are monitored.

Quality operations

The quality system around the file

Non-Conformities & CAPA

Record the deviation, find the root cause with 5-Whys or Ishikawa, and verify that the corrective action worked.

Internal audits

Checklists, findings and follow-up in one place, with each finding able to open a non-conformity.

File Library

Versioned, approved documents with access rights and search, so the current version is the only one in use.

See it on your own device

Book a demo on one of your own products and one regulation that applies to it.

Industries · In vitro diagnostics

Performance evidence and market rules in one place

Qurelio keeps your performance documentation next to the requirements it must answer, so you can see what each market asks for and where your evidence stands.

Public texts by market

European Union

EU IVDRMDCG guidanceIVDD (legacy)

United States

QMSR (21 CFR 820)21 CFR 80321 CFR 80721 CFR 830 · UDI

International

IMDRFMDSAP

The daily reality

Where diagnostics teams lose time

Today

  • A heavier regulation to absorbThe move from the former directive to the current regulation raised the level of evidence expected for many products.
  • Evidence that must stay currentPerformance data, stability reports and labelling evolve with each product change and have to stay traceable.
  • Guidance that keeps movingOfficial guidance is published and revised regularly, and each revision may change how an obligation is read.

With Qurelio

  • Obligations listed, not buriedThe regulation becomes a register of obligations you review one by one.
  • Evidence that follows the productWhen a document changes, re-run the evaluation and see what the new version covers.
  • Revisions compared for youA revised guidance is compared with the previous version, and only real differences are raised.

How Qurelio fits

Your assay, checked against the law that applies to it

Four engines, used in this order. Every AI result waits in Quarantine until your Quality Manager accepts it.

Product VaultUpload the product folder once. Qurelio reads it and builds a private Compliance Memory for that product.
Laws & Regulations PortalAdd the public texts that apply to your markets. Each one shows its source and its legal status.
Compliance EngineGet the obligations, a gap list and a weighted score, with every finding cited to the passage it comes from. Regulatory Monitoring HubBe alerted when a text changes in substance, and see which products and scores it touches.

Regulatory scope

What you can work from

Public texts Qurelio can analyse

Laws, regulations and official guidance that are free to reuse. You add them in the Laws & Regulations Portal and the Compliance Engine reads them in full.

Licensed standards, referenced only

Qurelio records the number and scope so your file stays complete. The text itself is never stored or analysed: you work from the copy you purchased.

ISO 13485ISO 14971ISO 15189IEC 62304IEC 62366-1ISO 15223-1

National texts for your own markets are added by you under your liability consent, then checked for legal clearance before they are monitored.

Quality operations

The quality system around the file

Non-Conformities & CAPA

Record the deviation, find the root cause with 5-Whys or Ishikawa, and verify that the corrective action worked.

Internal audits

Checklists, findings and follow-up in one place, with each finding able to open a non-conformity.

File Library

Versioned, approved documents with access rights and search, so the current version is the only one in use.

See it on your own product

Book a demo on one of your own products and one regulation that applies to it.

Industries · Pharmaceuticals

Quality records and regulatory obligations under control

Qurelio sets your manufacturing and quality documentation against public good-practice texts and regulations, and keeps watching them after the assessment is done.

Public texts by market

European Union

EU medicinal products codeRegulation 726/2004EU CTREU GMP (EudraLex Vol. 4)FMD

United States

21 CFR 210 / 21121 CFR 31421 CFR 1121 CFR 4

International

ICH Q1 · Q2 · Q3ICH Q7 · Q9 · Q10ICH E6 (GCP)ICH M4 (CTD)WHO GMPWHO GDPPh. Int.

The daily reality

Where pharmaceutical teams lose time

Today

  • Many texts for one siteManufacturing practice, distribution, stability and registration rules all apply at once, from several authorities.
  • Inspection readiness built by handEvidence for an inspection is assembled from procedures, batch records and reports each time, under deadline.
  • Deviations without a clear threadA deviation, its root cause and its corrective action are recorded in separate tools, so the link is hard to show.

With Qurelio

  • Each text assessed in its own rightAdd the texts one at a time and get a gap list and a score for each.
  • A dossier ready before the inspectionThe Audit-Readiness Dossier gathers the evidence already linked to your obligations.
  • One thread from deviation to proofThe non-conformity, its root cause, the action and its effectiveness check stay in one record.

How Qurelio fits

Your product, checked against the texts that govern it

Four engines, used in this order. Every AI result waits in Quarantine until your Quality Manager accepts it.

Product VaultUpload the product folder once. Qurelio reads it and builds a private Compliance Memory for that product.
Laws & Regulations PortalAdd the public texts that apply to your markets. Each one shows its source and its legal status.
Compliance EngineGet the obligations, a gap list and a weighted score, with every finding cited to the passage it comes from. Regulatory Monitoring HubBe alerted when a text changes in substance, and see which products and scores it touches.

Regulatory scope

What you can work from

Public texts Qurelio can analyse

Laws, regulations and official guidance that are free to reuse. You add them in the Laws & Regulations Portal and the Compliance Engine reads them in full.

Licensed standards, referenced only

Qurelio records the number and scope so your file stays complete. The text itself is never stored or analysed: you work from the copy you purchased.

Ph. Eur.USP-NFISO 15378

National texts for your own markets are added by you under your liability consent, then checked for legal clearance before they are monitored.

Quality operations

The quality system around the file

Non-Conformities & CAPA

Record the deviation, find the root cause with 5-Whys or Ishikawa, and verify that the corrective action worked.

Internal audits

Checklists, findings and follow-up in one place, with each finding able to open a non-conformity.

File Library

Versioned, approved documents with access rights and search, so the current version is the only one in use.

See it on your own product

Book a demo on one of your own products and one regulation that applies to it.

Industries · Cosmetics

Product files and market rules, kept audit-ready

Qurelio keeps each product file next to the public rules of the markets it is sold in, so a new launch or a new export market starts from what you already have.

Public texts by market

European Union

EU Cosmetics Regulation

United States

MoCRA21 CFR 700–740

The daily reality

Where cosmetics teams lose time

Today

  • A wide range to keep in orderDozens of formulas and variants each need their own file, labelling and safety evidence.
  • Different rules per export marketEach market asks for different things, in a different form.
  • Rules that are updated oftenIngredient restrictions and labelling requirements are amended regularly, and each change can touch many products.

With Qurelio

  • One vault for the whole rangeEach product has its file in the Product Vault, with its own regulatory profile.
  • Market by market, side by sideSee what each market’s regulation requires and what your file already covers.
  • One change, every product it touchesAn amended rule is traced to the products it affects.

How Qurelio fits

Your range, checked against the rules of each market

Four engines, used in this order. Every AI result waits in Quarantine until your Quality Manager accepts it.

Product VaultUpload the product folder once. Qurelio reads it and builds a private Compliance Memory for that product.
Laws & Regulations PortalAdd the public texts that apply to your markets. Each one shows its source and its legal status.
Compliance EngineGet the obligations, a gap list and a weighted score, with every finding cited to the passage it comes from. Regulatory Monitoring HubBe alerted when a text changes in substance, and see which products and scores it touches.

Regulatory scope

What you can work from

Public texts Qurelio can analyse

Laws, regulations and official guidance that are free to reuse. You add them in the Laws & Regulations Portal and the Compliance Engine reads them in full.

Licensed standards, referenced only

Qurelio records the number and scope so your file stays complete. The text itself is never stored or analysed: you work from the copy you purchased.

ISO 22716ISO 16128ISO 24444 / 24443ISO 29621GSO 1943GSO 2528

National texts for your own markets are added by you under your liability consent, then checked for legal clearance before they are monitored.

Quality operations

The quality system around the file

Non-Conformities & CAPA

Record the deviation, find the root cause with 5-Whys or Ishikawa, and verify that the corrective action worked.

Internal audits

Checklists, findings and follow-up in one place, with each finding able to open a non-conformity.

File Library

Versioned, approved documents with access rights and search, so the current version is the only one in use.

See it on your own range

Book a demo on one of your own products and one regulation that applies to it.

Qurelio Engines · Compliance Engine

Stay audit-ready, every day of the year

The Compliance Engine reads a public regulation, turns it into obligations, and checks each one against the evidence in your product files.

What it does

From a legal text to a list of gaps

Obligations, extracted and cited

Each obligation is listed with the passage of the regulation it comes from, in an Obligations Register you accept before it is used.

Evidence mapped to each obligation

Qurelio searches your Compliance Memory for the documents that answer an obligation and shows what it found, with a confidence indicator.

A score you can explain

Gaps are weighted by criticality into a compliance score and a five-level maturity model, with the history kept at each evaluation.

How it works

One evaluation, four steps

Every AI result lands in Quarantine first. Nothing becomes an official record until your Quality Manager accepts it.

  1. Choose a product

    Pick a product from the Product Vault. Its documents are already part of your Compliance Memory.

  2. Choose a regulation

    Select a public text from the Laws & Regulations Portal that applies to that product and market.

  3. Review the result

    Read the obligations, the evidence and the gaps. Edit, accept or reject each item.

  4. Act on the gaps

    Accepted gaps can become suggested non-conformities and corrective actions, each with an owner and a date.

What you get

Results that hold up in front of an auditor

  • Every finding cited to the passage of the source text.
  • A plain-language explanation of every gap.
  • A criticality-weighted compliance score and a five-level maturity model.
  • Re-evaluation and score history, to show progress over time.
  • AI-suggested non-conformities and corrective actions from accepted gaps.
  • A visible AI label and a confidence indicator on every AI output.

Availability

What each plan includes

Starter

Included, for 2 active regulations and 4 AI evaluation runs per year. Re-evaluation on demand.

Professional

Included, with unlimited regulations, fair-use evaluation runs and automatic re-evaluation.

Enterprise

Included, unlimited, with configurable scoring and maturity model.

Early Access Pilot

Same scope as Professional.

See your first gap list

Book a demo on your own products, or see how it connects to the next engine.

Qurelio Engines · Regulatory Monitoring Hub

Never be surprised by a regulation again

The Regulatory Monitoring Hub watches the public texts that apply to your products and tells you when one changes in a way that matters.

What it does

Watching, filtering and pointing at what is affected

Watches the laws that apply to you

Sources in your monitored registry are checked on a schedule, so a change is seen when it is published.

Separates substance from form

Renumbering, typography and layout edits are filtered out. You are alerted for changes that alter an obligation.

Finds what you did not know to look for

When a regulation you never listed appears relevant to your products and markets, Qurelio proposes it for your review.

How it works

From a published change to an updated score

Every AI result lands in Quarantine first. Nothing becomes an official record until your Quality Manager accepts it.

  1. Register your sources

    Add the public texts you rely on to the monitored registry. Each source is cleared legally before it is watched.

  2. A change is detected

    Qurelio compares the new version with the previous one and keeps only the differences of substance.

  3. See the impact

    The alert names the obligations, products and scores the change touches, with a severity level.

  4. Decide what to do

    Accept the analysis, re-run the evaluation and open the actions needed.

What you get

Alerts that tell you what to do next

  • A registry of monitored sources, each with its legal status.
  • Scheduled change detection, with cosmetic changes filtered out.
  • Impact analysis on your obligations, products and scores.
  • Detection of missing regulations for your products and markets.
  • Alerts ranked by severity.
  • Automatic re-evaluation of the scores a change affects.

Availability

What each plan includes

Starter

Not included. Regulations are assessed on demand with the Compliance Engine.

Professional

Included in full.

Enterprise

Included in full, across all sites.

Early Access Pilot

Included in full, with priority for adding your national sources.

Know about the next change first

Book a demo on your own products, or see how it connects to the next engine.

Qurelio Engines · Audit Automation

Run audits without chasing a single email

Plan internal audits, let AI draft the checklists, and turn every finding into an action that is followed to closure.

What it does

Less preparation, more auditing

AI-drafted checklists

Define the audit programme and its scope. AI drafts the checklist for you to review and accept before the audit starts.

Reminders and responses handled

Auditors are assigned, reminders are sent and responses are collected in the platform instead of in mailboxes.

From finding to action

A finding can open a non-conformity directly, with the link kept from observation to closure.

How it works

An audit from plan to closure

Every AI result lands in Quarantine first. Nothing becomes an official record until your Quality Manager accepts it.

  1. Plan

    Create the audit, set its scope and dates, and assign the auditors.

  2. Prepare

    Review the drafted checklist, adjust the questions and accept it.

  3. Conduct

    Record answers and evidence against each item as the audit runs.

  4. Follow up

    Turn findings into non-conformities and track the corrective actions.

What you get

Audits that leave a clear trail

  • Internal audit programmes, checklists and findings in one place.
  • Findings linked to non-conformities and corrective actions.
  • An audit-readiness score that shows where you stand before the auditor arrives.
  • An Audit-Readiness Dossier that gathers the evidence for an audit.
  • A scoped access for external auditors.
  • Calendar and reminders for upcoming audits.

Availability

What each plan includes

Starter

Internal audits, checklists and findings that open non-conformities.

Professional

Adds the audit-readiness score and the Audit-Readiness Dossier.

Enterprise

Adds scoped access for external auditors.

Early Access Pilot

Same scope as Professional.

Prepare your next audit in Qurelio

Book a demo on your own products, or see how it connects to the next engine.

Qurelio Engines · Non-Conformities & CAPA

Solve issues at the root, not at the symptom

Record a non-conformity from any source, find its real cause, and prove that the corrective action worked.

What it does

One thread from the deviation to the proof

Capture from any source

Audits, quality control, complaints or a gap found by the Compliance Engine: each one becomes a record with an owner.

Root-cause tools built in

Run a 5 Whys, an Ishikawa diagram or an 8D without leaving the record, with AI suggestions you can accept or discard.

Effectiveness, verified

An action is not closed when it is done. It is closed when its effectiveness check confirms the problem did not come back.

How it works

The CAPA lifecycle

Every AI result lands in Quarantine first. Nothing becomes an official record until your Quality Manager accepts it.

  1. Record

    Describe the non-conformity, its source and its severity, and assign an owner.

  2. Analyse

    Find the root cause with the method that fits the problem.

  3. Act

    Plan corrective and preventive actions with owners and due dates, followed on the Kanban board.

  4. Verify

    Check effectiveness after implementation, then close with the evidence attached.

What you get

A closed loop, every time

  • Non-conformity records with source, severity, owner and status.
  • 5 Whys and Ishikawa analysis, and 8D for complex problems.
  • Corrective and preventive actions with due dates and reminders.
  • Effectiveness verification before closure.
  • The Action Plan Center, a Kanban board and a calendar to follow the work.
  • Full traceability from the finding to the closed action.

Availability

What each plan includes

Starter

Non-conformities, the CAPA lifecycle, 5 Whys and Ishikawa.

Professional

Adds 8D.

Enterprise

Adds Supplier Quality Management, including supplier corrective action requests.

Early Access Pilot

Same scope as Professional.

Close the loop on your next deviation

Book a demo on your own products, or see how it connects to the next engine.

Qurelio Engines · Controlled Documents & File Library

One source of truth: versioned, approved, easy to find

The File Library keeps your procedures, records and product files in one place, with the current version always the one in use.

What it does

Documents under control, without the shared-drive maze

Approval that leaves a trail

Documents go through review and approval before they are published, and each step is recorded.

No more rogue versions

Old versions are archived automatically, so the current procedure is the only one people find.

Found in seconds

Search covers the content of documents, including scanned ones, thanks to text extraction.

How it works

From a draft to the version in use

The same documents feed your Compliance Memory, so what you approve here is what the Compliance Engine reads.

  1. Add

    Upload a document or a whole folder and file it against a product or a process.

  2. Review

    Send it to the reviewers and approvers defined for that type of document.

  3. Publish

    The approved version becomes the current one and the previous one is archived.

  4. Use

    People with the right access find it by search, and audits and evaluations cite it as evidence.

What you get

A library an auditor can walk through

  • Version history for every document.
  • Review and approval steps, recorded.
  • Access rights by role and by document.
  • Search across document content.
  • Text extraction from scanned documents.
  • Documents linked to products, audits and evaluations.

Availability

What each plan includes

Starter

Included in full: versioning, approval, access rights and search.

Professional

Included in full.

Enterprise

Included in full, with audit-log export and retention settings.

Early Access Pilot

Same scope as Professional.

Put your documents in order

Book a demo on your own products, or see how it connects to the next engine.

Qurelio Engines · Live KPI Dashboards

See your quality posture at a glance

Compliance scores, open actions, audits and quality indicators in one view that is always up to date.

What it does

Numbers you can trust and trace

Live, not end-of-month

Indicators update as records change, so the dashboard reflects today and not the last report.

Views by role

A quality manager, a site lead and a director each see what they need to decide.

From the number to the evidence

Open any figure to see the audits, findings and documents behind it.

How it works

From records to a report

Dashboards are built from the records already in Qurelio. There is nothing to compile by hand.

  1. Work as usual

    Evaluations, audits, non-conformities and actions feed the indicators as they are recorded.

  2. Open the dashboard

    See scores per product and regulation, open actions and upcoming audits.

  3. Look closer

    Filter by date and drill down into the records behind an indicator.

  4. Share

    Export a scorecard or a presentation for a management review or a client.

What you get

One view for the whole quality system

  • Compliance score per product and per regulation.
  • Open actions, overdue items and upcoming audits.
  • A heatmap that shows where gaps concentrate.
  • An audit-readiness score.
  • Drill-down and date filtering.
  • Exports to PDF, Excel and PowerPoint.

Availability

What each plan includes

Starter

Standard dashboard and KPIs.

Professional

Full dashboard with heatmap, audit-readiness score, drill-down, date filtering and exports.

Enterprise

Adds a consolidated multi-site view and branded exports.

Early Access Pilot

Same scope as Professional.

See your own numbers

Book a demo on your own products, or see how it connects to the next engine.

Product · Overview

One platform for compliance and quality, from the product file to the audit

Qurelio turns your product files and the public laws of each market into audit-ready proof, and keeps it current as the rules change.

  • 4engines that work as one
  • 5pillars, from memory to control
  • 0licensed standards stored

The platform

Five pillars, built to work together

Compliance Engine

Reads a public regulation, lists its obligations and checks each one against your evidence. You get a gap list and a score, with every finding cited.

Context & Memory

Your company profile and product files become a private Compliance Memory.

Regulatory Monitoring Hub

Watches the texts you rely on and alerts you to changes of substance.

Quality Operations

Non-conformities, CAPA, audits, documents, training and action plans.

Intelligence & Control

The Legal Guardrail, the Quarantine inbox, dashboards and the audit trail.

The flow

From a folder of documents to a monitored score

Four engines, used in this order. Every AI result waits in Quarantine until your Quality Manager accepts it.

Product VaultUpload the product folder once. Qurelio reads it and builds a private Compliance Memory for that product.
Laws & Regulations PortalAdd the public texts that apply to your markets. Each one shows its source and its legal status.
Compliance EngineGet the obligations, a gap list and a weighted score, with every finding cited to the passage it comes from. Regulatory Monitoring HubBe alerted when a text changes in substance, and see which products and scores it touches.

Who uses it

One workspace, four points of view

Quality manager

Reviews and accepts AI results, runs audits and follows corrective actions to closure.

Regulatory affairs lead

Adds the texts that apply to each market and follows what changes.

Executive

Sees where the company stands and what an open gap puts at risk.

Quality consultant

Prepares assessments faster for the manufacturers they support.

AI-augmented and human-governed. Never autonomous.

Every AI result waits in Quarantine until your Quality Manager accepts it.

See the platform on your own products

A live session on one product and one regulation that applies to it.

Product · Why Qurelio

What sets it apart from a classic quality system

A quality system records what you did. Qurelio also reads the law, checks your evidence against it and tells you when the law moves.

Reads
Public laws and regulations only.
Decides
Nothing. Your Quality Manager does.
Cites
The source passage, on every finding.

Side by side

Three ways to run compliance

Spreadsheets and shared drivesClassic quality softwareQurelio
Lists the obligations of a regulation——
Checks your documents against each obligation——
Watches the regulations for changes——
Keeps every AI result for human reviewNo AIVaries
Refuses licensed standards it may not hostNot applicableVaries
Non-conformities, CAPA and auditsBy hand
Document versions and approvalBy hand

The legal limit is not a constraint we apologise for. It is the product.

Qurelio works only with texts you are allowed to use, and blocks the rest.

Four reasons

What you can rely on

Legal by design

Only public, freely reusable legal texts are ingested. That rule is enforced by the platform itself, not by a policy document.

Specific to you

Results come from your own documents and your own markets, not from generic text.

Human-governed

Every AI result starts in Quarantine and becomes usable only when your Quality Manager accepts it. Qurelio never decides for you.

Always current

When a text changes, the obligations and scores it affects are flagged for re-evaluation.

Compare it with what you use today

Bring one product and one regulation. We run the assessment with you.

Product · Book a demo

See it working on your own products and markets

Tell us what you make and where you sell it. We prepare the session around that, not around a generic script.

What happens next

Three steps, no commitment

  1. You send the request

    A few lines about your products, markets and the regulations that worry you most.

  2. We run a live session

    We walk through Qurelio on your own context, in French or in English, and answer your questions.

  3. You receive a quote

    A plan scoped to your products, regulations and team, with onboarding included.

Choose a time that suits you

Pick an available slot and tell us about your company. We confirm every request within 48 hours. All times are shown in your local timezone.

Loading available times…

About

Compliance you can defend, with a human in control

Qurelio is an AI compliance and quality platform for regulated manufacturers. It turns your own documents and public regulations into a living, monitored and audit-ready compliance system.

Sectors
Medical devices, in vitro diagnostics, pharmaceuticals and cosmetics.
Reach
Manufacturers worldwide.
Languages
French and English.
Built by
Aggregax.

Compliance knowledge should not live in one expert’s head.

Too often it sits in PDFs, emails and spreadsheets, and a change is discovered after a failed audit or a lost contract.

What we do

Three things, combined in one platform

A private Compliance Memory

Built from your own product and process documents, so every result is specific to your organisation and not generic text.

Assessment against public law only

Your products are evaluated against laws and regulations that are free to reuse. Licensed standards are detected and refused.

Continuous regulatory monitoring

Changes are detected, their impact on your obligations is analysed, and regulations you had not listed are surfaced.

How we work

Principles we do not trade away

Legal by design

Only public, freely reusable legal texts are ingested. That rule is enforced by the platform itself, not by a policy document.

Human-governed

Every AI result starts in Quarantine and becomes usable only when your Quality Manager accepts it. Qurelio never decides for you.

Precise

Every finding cites the passage of the source text it comes from, so you can check it in seconds.

Yours alone

Your data stays in your own tenant environment and is never used to train a model.

The company behind Qurelio

Powered by Aggregax

Aggregax is a healthtech company founded in 2025. Its mission is to bridge technology and life sciences.

Its team brings together engineers, biologists and healthcare professionals. Qurelio is the product that carries that experience into compliance and quality.

Visit aggregax.com

Values

  • Integrity
  • Innovation
  • Collaboration
  • Excellence

Empowering tomorrow’s systems, today

Meet the team and see the platform on your own products.

Security & Compliance

Built so you can answer your own auditors

How Qurelio handles the regulatory content it reads, the results its AI produces, and the data you entrust to it.

Legal Guardrail

Only content you are allowed to use

Three checks stand between a file and the AI.

  1. Consent before every upload

    Before a regulatory text is added, the user confirms they are entitled to use it. That acceptance is recorded.

  2. Licensed standards are detected

    ISO, IEC and equivalent standards are recognised on upload and blocked, even when you hold your own licence.

  3. Blocked content goes nowhere

    A blocked file is never stored, never indexed and never sent to an AI model.

AI governance

No AI result acts on its own

Qurelio helps you work faster. It does not make compliance decisions and does not replace your regulatory judgement.

  • Every AI output is created in Quarantine and carries a visible AI label.
  • Your Quality Manager can edit, accept or reject it; nothing is executable before acceptance.
  • The history shows who accepted what, and when.
  • Every finding cites the passage of the source text it comes from, with a confidence indicator.

Your data

Isolated, traceable and never used for training

Tenant isolation

Each client works in a dedicated tenant environment. No other client can reach your products, profiles, analyses or audit records.

Append-only audit trail

Actions are recorded in a trail that can be added to but not rewritten.

No model training

Your documents are never used to train a model.

Data Processing Agreement

Signed before any data enters the system. You remain the controller of your data.

Roles and access

Access follows roles. Enterprise adds custom roles, single sign-on and a scoped access for external auditors.

Qurelio does not hold a quality or security certification today. Aggregax, the company behind Qurelio, is working toward recognised standards for quality management, information security and AI management.

Need details for a supplier assessment?

Ask for our Data Processing Agreement or send us your security questionnaire.

Help Center

Answers for your first weeks with Qurelio

The questions teams ask most when they start. For anything else, write to support@qurelio.com.

Getting started

Setting up your workspace

Your company information, at least one product folder, and the public regulation you want to assess it against. The onboarding wizard guides you through four steps: company identity, activity and products, markets and compliance, and quality team.

The organisational profile is what makes results specific to you. It lets the AI ignore what does not apply to your activity, products and markets.

Yes. Onboarding is included in every plan and there is no implementation fee.

Regulations

Adding and analysing regulatory texts

Public laws, regulations, decrees and official guidance that are free to reuse. Each text in your workspace shows its source and its legal status.

The upload is detected and blocked. Qurelio tells you which standard to acquire and lets you reference it by number and scope while you work from your own copy.

On plans that include the Regulatory Monitoring Hub, sources are checked on a schedule. Cosmetic changes are filtered out and you receive an alert with the impact on your obligations and scores.

AI results

Reviewing what the AI produces

In the Quarantine inbox. Each item can be edited, accepted or rejected, and only accepted items become part of your quality system.

Open it: the finding shows the passage of the regulation it relies on and the evidence found in your documents, with a confidence indicator.

Support

How to reach us, by plan

Starter

Email support, answered within 48 hours.

Professional

Priority email and chat support.

Enterprise

Dedicated Customer Success Manager and a contractual service level.

Did not find your answer?

Write to the support team, or read the pricing questions.

Documentation

How each part of Qurelio works

An index of the platform, chapter by chapter.

Guides
Shared with your team during onboarding.
API reference
For Enterprise workspaces.
Languages
French and English.

Product Vault

The product registry and the memory built from your files.

  • Product registry and regulatory profile
  • Folder ingestion
  • Text extraction from scanned documents
  • The private Compliance Memory

Laws & Regulations Portal

Where public texts enter your workspace.

  • Adding a public regulation
  • The liability acceptance
  • Detection of licensed standards
  • Source and legal status of each text

Compliance Engine

From obligations to a score.

  • Obligation extraction and the Obligations Register
  • Evidence mapping and the gap list
  • The criticality-weighted score
  • The five-level maturity model

Regulatory Monitoring Hub

Keeping watch after the assessment.

  • The monitored source registry
  • Scheduled change detection
  • Impact analysis and severity-based alerts
  • Missing-regulation detection

Quality operations

The modules your team uses every day.

  • Non-conformities and the CAPA lifecycle
  • 5 Whys, Ishikawa and 8D
  • Internal audits, checklists and findings
  • File Library, action plans and training

Control layer

What applies everywhere.

  • Quarantine inbox: review, edit, accept or reject
  • Roles and permissions
  • Dashboards, exports and the audit-readiness score
  • Append-only audit trail, public API and webhooks

Looking for a specific answer?

The Help Center covers the most common questions.

Blog

Notes on regulation, quality and AI you can audit

The first articles are being written. Here is what we will publish.

Status
No article published yet.
Newsletter
One email per month, no spam.

Method

Reading a regulation as obligations

How a legal text becomes a list of things to prove, and how to link each one to evidence.

Watch

Regulatory change, explained

What changed in a text, whether it matters in substance, and who it affects.

AI

AI in a regulated environment

Human review, citations and disclosure: what auditors expect when AI is part of the work.

Practice

Staying audit-ready

Practical methods for non-conformities, corrective actions and evidence that hold up all year.

Be the first to read it

Leave your email in the newsletter form at the bottom of this page.

Customer Stories

The first stories are being written now

Qurelio is in its Early Access Pilot. We will publish results here once pilot clients have agreed to share them, and not before.

Early Access Pilot

How a pilot runs

The programme is open worldwide to the first five manufacturers who join.

  1. You apply

    Write to contact@qurelio.com or book a demo, and tell us about your products and markets.

  2. We set up your workspace with you

    A dedicated onboarding session, at no charge, with the complete Professional plan.

  3. Your regulatory sources come first

    Your national sources are added to the monitored registry in priority, each subject to legal clearance.

  4. Your feedback shapes the product

    You have a direct line to the product team, and scope can be customised after the pilot.

What a story will show

Measured, with the client’s agreement

The starting point

Tools in use, products and target markets.

What changed

In audit preparation and in following regulatory updates.

What did not work

And what we changed in the product as a result.

Become one of the first five

Write to contact@qurelio.com or book a demo to apply for the pilot.

Partners

Work with Qurelio for your clients

We are opening conversations with the firms and organisations that already help manufacturers stay compliant.

Programme
Not formal yet. Built with you.
Contact
contact@qurelio.com

Who we want to talk to

Three kinds of partners

Quality and regulatory consultants

Use Qurelio with your clients to prepare assessments faster, while your expertise stays the deciding voice.

Industry and export organisations

Help your members follow the regulations of the markets they export to.

Technology partners

Connect your tools through the public API and webhooks available on the Enterprise plan.

There is no formal partner programme yet. Tell us what you do and who you serve, and we will build the arrangement with you.

Start the conversation

Write to contact@qurelio.com with a short description of your activity.

Careers

Build the tools quality teams rely on

There are no open positions at the moment. We still read every message from people who want to work on this problem.

Who we look for

Three kinds of experience matter here

Regulatory and quality practice

You have prepared audits, written technical files or managed corrective actions, and you know what a usable tool looks like.

AI and software engineering

You build systems whose results can be checked, cited and explained to an auditor.

Product and design

You make dense professional work calm and clear on screen.

To send a spontaneous application, write to contact@qurelio.com and tell us what you would like to work on.

Press

Qurelio in brief

Qurelio is an AI compliance and quality platform for regulated manufacturers. It builds a private Compliance Memory from a company’s own documents, evaluates products against public laws and regulations only, monitors those regulations for changes, and keeps every AI result in quarantine until a person approves it.

Name
Written "Qurelio", with a capital Q.
Tagline
Empowering tomorrow’s systems, today.
Press contact
contact@qurelio.com

Key facts

What to know

Product
AI compliance and quality platform, delivered as a web application.
Sectors
Medical devices, in vitro diagnostics, pharmaceuticals and cosmetics.
Stage
Early Access Pilot, open worldwide to the first five manufacturers.
Languages
French and English.
Company
Built by Aggregax, a healthtech company founded in 2025.

Brand

Logo and colours

Logo files are available on request. Please do not redraw, recolour or stretch the wordmark.

Qurelio Blue#0788CCInk#14273BQurelio Yellow#F8CC08

Press enquiries

Write to contact@qurelio.com. We answer interview and information requests ourselves.

Contact us

Tell us about your products, your markets and your compliance challenges. We’ll show you what Qurelio can do with them.

We typically reply within one business day.

Qurelio: The AI Compliance & Quality OS