Your MDs and IVDs on the EU market, on defined timelines and at a fixed cost.

Ardeevo is the AI-native regulatory service that offers support in drafting technical and quality management system documentation, expert-reviewed, for MedTech companies.

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Ardeevo RegulatoryClark drafts, an expert reviews.
C
Clark

What does your device do?

YouOur app analyses photos of skin spots for dermatologists. What is the regulatory path?

C
Clark

The first step: what is the intended purpose?

YouImage analysis for the early diagnosis of melanoma.

C
Clark is checking the sources
  • MDR 2017/745
  • IVDR 2017/746
Message Clark…
Mission

Healthcare innovation must reach patients, not stop at regulation.

01 · Services

Create your documentation.
Receive a reviewed service.

Choose the service with a clear path, expert-reviewed documents on defined timelines and at a fixed cost: from regulatory uncertainty to submission-ready files for CE marking under the MDR and IVDR.

01
Regulatory Compass
Qualification · Classification · Pathway

Plan the right regulatory path.

Plan your path and define the regulatory perimeter before documentation work becomes costly, fragmented or late.

  • Qualification & classification
  • Preliminary regulatory roadmap
  • Identification of key decision points
  • Notified Body scope matching
  • Expert-reviewed regulatory rationale
Value
Turn regulatory uncertainty into a reviewed, traceable strategy for CE marking under the MDR and IVDR.
02
Technical File Readiness
Documentation · Evidence · Consistency

From fragmented documents to a coherent file.

Prepare and review technical documentation, clinical or performance evidence, labelling and pre-submission consistency.

  • Technical documentation structuring
  • Clinical or performance evaluation
  • IFU and labelling review
  • Completeness checks
  • Document consistency across claims, intended purpose, risks, evidence and documentation
Value
Prepare reviewed, coherent and submission-ready files.
03
Lifecycle Compliance
Monitoring · Change impact · Post-market surveillance

Stay aligned after the first submission.

Monitor regulatory updates, assess product and process changes, and manage post-market activities in a structured way.

  • Regulatory monitoring
  • Change impact assessment
  • Post-market activity structuring
  • Documentation impact mapping
  • Lifecycle compliance workflow support
Value
Turn regulatory changes, product updates and post-market obligations into structured compliance actions.
02 · How it works

Prepare and submit your files.
Ardeevo reviews.

Every stage in developing the technical documentation is monitored.

Step 1AI draft

The Clark agent structures the file.

Each section is drafted from your inputs and the information on your device, with its regulatory references already in place.

Step 2Producing documentation

You work on your file with the Clark agent.

You produce the technical and quality management system documentation with Clark's support.

Step 3Expert-reviewed

A regulatory expert reviews the work.

Every result is reviewed before you submit the documentation to a Notified Body.

03 · Why Ardeevo?

Built for regulatory affairs that can't rely on generic AI.

Ardeevo is a specialist AI service for Regulatory Affairs, supervised by industry experts. It is not an eQMS and does not provide consulting. Regulatory Affairs work is demanding. Generic AI tools can draft text, but they don't provide a structured regulatory workflow, expert review or traceable outputs designed for regulatory decision-making. Ardeevo combines AI-native workflows with integrated regulatory review to help teams produce structured results.

01

Execution in a single flow

Reduce manual coordination across documents, templates, checklists and fragmented workflows.

“One flow, milestone-based deliveries”

02

Reviewed outputs

Results are reviewed as part of the service.

“Expert-reviewed, not auto-generated”

03

Predictable cost

Move from open-ended advisory hours to defined regulatory outputs and milestone-based delivery.

“Fixed-cost milestones”

04 · Who it's for

Built for startups and innovative SMEs.

Ardeevo is designed for teams that need to build regulatory strategies for devices and services under the MDR and IVDR. Support in preparing technical documentation and managing regulatory work across the product and service lifecycle in the European market.

Founder team

Regulatory path, timelines and costs defined before the documentation work begins.

Regulatory team

Drafts with the regulatory references already in place, reviewed by an expert.

Quality team

Quality system documentation consistent with the technical file, even as the product changes.

R&D team

Requirements and evidence to produce, identified from the design stage.

Consultant team

Structured files to work on: judgement and the client relationship stay with the consultant.

Clinical team

Clinical or performance evaluation consistent with intended purpose, claims and risks.

MD & IVD manufacturers Startups preparing their regulatory path SMEs with lean regulatory or quality teams Medical R&D projects moving towards certification Teams relying on consultants & fragmented workflows
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05 · FAQ

Questions and answers.

What is Ardeevo?

Ardeevo supports manufacturers in preparing reviewed regulatory documents for their CE marking path under MDR and IVDR.

It does not replace the manufacturer's responsibility, does not replace the Notified Body and does not guarantee certification or market access.

It does not sell generic AI-generated documents: it delivers reviewed documents through an AI model verified by regulatory affairs experts.

How is Ardeevo different from generic AI tools?

Generic AI tools can generate text, but they do not provide a structured regulatory workflow, expert review or outputs designed for regulatory decision-making.

Ardeevo combines AI-powered workflows with regulatory expertise to deliver reviewed outputs that can be used in the next step of your regulatory process.

Is expert review included in the service?

Yes.

Every service combines AI-powered workflows with expert review integrated into the service. The objective is not simply to generate documents, but to deliver reviewed outputs with a clear regulatory rationale.

AI accelerates the work. Experts review the outcome.

When can I use Ardeevo?

At any stage of your regulatory path.

From regulatory strategy assessments to the drafting of Technical Files and post-market monitoring.

Do I need to replace my consultant or regulatory team?

No.

Ardeevo is designed to work alongside founders, regulatory teams, quality teams and external consultants.

The goal is to reduce manual effort, give the documentation consistency and deliver on defined timelines, while preserving the expertise and decision-making responsibilities already present in your organisation.

Does Ardeevo guarantee certification or CE marking?

No.

Ardeevo is not a Notified Body and does not guarantee certification or market access.

The manufacturer remains responsible for regulatory decisions and product compliance. Ardeevo supports the process with structured workflows and reviewed outputs, with which teams prepare regulatory milestones on defined timelines.

Want to turn regulatory complexity into a reviewed strategy?

Start with a Regulatory Compass assessment and identify the next milestone to structure your strategy.

Talk to a regulatory expert. AI drafts, the expert reviews.

Book a demo