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SANTVIA · Sovereign compliance

European compliance, on firm dates, within an SME's reach.

Nisera turns NIS2, CRA, DORA, Data Act and AI Act into a dated timeline, a clear list of obligations and an evidence file. The AI drafts, you approve, everything is versioned. Sovereign, hosted in the European Union.

Self-hostable on your own servers Coming soon · demo on request 24-hour CRA-Reporter Hosted in the EU
nisera.eu · échéancier
  • 11 Sep
    CRA — 24-hour notice

    Report exploited incidents and vulnerabilities to ENISA.

  • 27 Sep
    HDS decree no. 2026-209

    Health-hosting contracts to be updated.

  • 11 Oct
    DDADUE — energy audit

    2.75 GWh threshold; fine up to 2% of turnover.

  • 2 Dec
    AI Act — labelling

    Transparency and labelling of AI-generated content.

In brief

What is Nisera?

Nisera is a regulatory-compliance copilot for SMEs. It turns European regulations (NIS2, CRA, DORA, Data Act, DDADUE, AI Act, EAA) into a firm-date timeline, concrete obligations and a verifiable evidence file. We sell the outcome — a compliant file — not just software. Sovereign, hosted in the European Union.

The problem

A regulatory wave, and no one to carry it

In a few months Europe is stacking up CRA, DDADUE, Data Act, AI Act, EAA — and soon the NIS2 transposition. Large groups have compliance departments; SMEs discover the deadlines at the last minute, unsure what applies to them, where to start, or how to prove they are compliant.

Deadlines that hit fast

CRA's 24 hours since September, DDADUE in October, AI Act in December: the deadlines are here, not "someday".

Unclear scope

Which texts really target you? Vendor, manufacturer, subcontractor: each profile has its own obligations. Sorting by hand is exhausting.

Missing evidence

Being compliant isn't enough: you must prove it, file in hand, on the day of an audit or an incident.

The solution

Nisera does the work, you approve

A "draft, approve, version" approach: the AI prepares the file, a human decides, every version is traced. Compliance becomes a marked path, not a wall.

A map of your obligations

Answer a few questions about your business: Nisera identifies the regulations that concern you and sets the rest aside. No more scope guesswork.

Firm-date timeline

Each obligation becomes a dated, prioritised task with an action plan. You know what to do, in what order, by when.

CRA-Reporter, incident within 24 h

The Cyber Resilience Act requires early notification to ENISA within 24 h. Nisera prepares the alert, keeps the record and helps you meet the deadline.

Versioned evidence file

Register of measures, policies, contracts and addenda (including HDS) gathered and timestamped: the file ready for an audit or inspection.

Regulatory timeline

The firm dates Nisera keeps you on

Nisera focuses on texts already applicable with certain deadlines, without waiting for the NIS2 transposition. Here are the key milestones tracked.

The dates cited are real and sourced. Nisera invents no deadline, penalty or certification. The timeline is kept up to date through SANTVIA's sovereign regulatory watch.
Two ways to work

The outcome delivered, then maintained

"Land with the service, expand with the SaaS": we first deliver a compliant file, then keep compliance current over time.

The compliant file

Service, outcome delivered
  • Diagnosis of your regulatory scope
  • Dated action plan, prioritised by deadline
  • Evidence file built and versioned
  • Contract and addendum templates (including HDS)

Ongoing compliance

Recurring, under control
  • Watch for new deadlines that concern you
  • Continuous update of the evidence file
  • CRA-Reporter ready for a 24-hour incident
  • Compliance dashboard by regulation
Product status. Nisera is coming soon; a demo is available on request. Write to contact@santvia.eu for a presentation tailored to your sector — no price is shown until the offer opens.
Verifiable sovereignty

A compliance copilot that follows the rules itself

Entrusting your compliance to a tool hosted outside the EU would be a contradiction. Nisera is sovereign by design.

See the SANTVIA proof sheet →

Who it's for

Compliance without a full-time firm

Software vendor

Ready for the CRA

Connected products and software: vulnerability management, 24-hour notification, technical documentation. Nisera maps out CRA compliance without mobilising a whole team.

Industrial SME

DDADUE and energy

Above the 2.75 GWh threshold, the energy audit becomes mandatory. Nisera dates the deadline, prepares the file and tracks implementation.

Healthcare player

HDS contracts up to date

The HDS decree extends the scope to messaging and backups. Nisera provides addendum templates and gathers the evidence — shared with Sekervia, Kondensa and Salvenia.

Get ahead of your deadlines

Request a demo tailored to your sector: we map your obligations and show you the timeline and the evidence file.

FAQ

Frequently asked questions

What is Nisera?

Nisera is a regulatory-compliance copilot for SMEs: it turns European regulations (NIS2, CRA, DORA, Data Act, DDADUE, AI Act, EAA) into a firm-date timeline, a list of obligations and an evidence file. The AI drafts, you approve, everything is versioned. Sovereign and hosted in the European Union.

Does Nisera make me NIS2-compliant?

The French NIS2 transposition has not yet been voted. Nisera prepares you for it while first having you handle the texts already applicable on firm dates (CRA, DDADUE, Data Act, AI Act, EAA, DORA for the financial sector), so you don't face compliance at the last minute.

What is the CRA-Reporter?

Since 11 September 2026 the Cyber Resilience Act requires early notification of incidents and actively exploited vulnerabilities to ENISA, within 24 hours. Nisera's CRA-Reporter prepares this notification, keeps a record of the alert and helps you meet the deadline.

Does Nisera invent certifications?

No. Nisera displays no certification it hasn't obtained. Sector certifications (HDS, SecNumCloud) are in progress and presented as such. Nisera produces a verifiable evidence file, not vanity labels.

Who is Nisera for?

For SMEs and mid-caps affected by the European regulatory wave: software vendors and makers of connected products (CRA), industrial and energy-intensive companies (DDADUE), players handling data or AI (Data Act, AI Act), and their subcontractors. Nisera aims at accessibility: compliance without a full-time firm.

Is Nisera available today?

Nisera is coming soon; a demo is available on request. Write to contact@santvia.eu for a presentation tailored to your sector and deadlines.

SANTVIA, the sovereign galaxy

Nisera is SANTVIA's compliance brick: digital communication, protection and compliance, hosted in Europe. Proof rather than promises, a sovereign copilot, a single identity.

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