Skip to content

Pricing

One subscription for each device

The subscription opens every tool for the device it covers. The consulting routes further down are for when you want Venitara's regulatory experts to do the work with you. Every price is net and excludes VAT, and government and notified body fees are always on top and never blended in.

The subscription

Per device. It opens every tool, and that device's Word documents, for everyone in your company. At present it also includes your company's quality system procedures. Expert review of a document is bought on its own.

EUR 349 excl. VAT per month

Or EUR 3,799 excl. VAT per year. The annual price is a 9.3% discount on twelve months at the monthly rate.

Checking your devices…

Consulting routes

For when you want Venitara's regulatory experts to do the work with you. Route A is bought one Act at a time, and the platform is billed on its own line. Route B is one figure for the whole journey: it includes the platform and runs through to Certification, which is why it is marked most complete.

Route A. Act by Act

EUR 58,376 excl. VAT
130 hours of senior regulatory work. Assurance reached: Attestation.
  • Consulting across the four Acts, EUR 50,000 excl. VAT
  • Platform over the 24-month working term, EUR 8,376 excl. VAT, billed on its own line
Most complete

Route B. Full service

EUR 49,000 excl. VAT
170 hours of senior regulatory work. Assurance reached: Certification.
  • Includes the platform over the 24-month working term
  • Includes Certification
  • Saves EUR 9,376 excl. VAT against Route A, a 16% saving

The four Acts

Route A bought Act by Act. Each document can also be bought alone as a single attestation at the price beside it, excl. VAT. Act package, route, and Certification prices are for a Class IIa reference device. Device class and scope adjust them in a written quote before anything is billed. Single-document attestation prices are flat.

Act 1. Understand & position

12 hours, EUR 4,600 excl. VAT
  • Qualification determinationEUR 650
  • EU AI Act applicability determinationEUR 650
  • Intended purpose statementEUR 850
  • Classification rationale, Annex VIIIEUR 850
  • GSPR applicability screenEUR 850
  • Regulatory strategy, first marketEUR 1,300

Act 2. Build the evidence

38 hours, EUR 14,600 excl. VAT
  • Usability engineering plan, IEC 62366EUR 1,300
  • Design and development planEUR 1,750
  • Post-market surveillance planEUR 1,750
  • Clinical evaluation planEUR 2,150
  • Risk management plan and file, ISO 14971EUR 4,350
  • QMS core procedures, ISO 13485EUR 5,200
  • Software development plan, IEC 62304
    Add-on
    EUR 2,600

Act 3. Quality, compliance & certify

48 hours, EUR 18,500 excl. VAT
  • Labelling and instructions for useEUR 1,750
  • Usability summative evaluation reportEUR 1,750
  • Risk management reportEUR 2,150
  • Test report review: biocompatibility, electrical safety, EMCEUR 2,150
  • GSPR checklist, completed with evidence linksEUR 3,500
  • Design verification and validation reportsEUR 3,500
  • Clinical evaluation reportEUR 6,100
  • Software V&V, SOUP inventory, cybersecurity
    Add-on
    EUR 3,500

Act 4. Launch, fund & govern

32 hours, EUR 12,300 excl. VAT
  • Declaration of conformityEUR 850
  • Authorised representative and PRRC appointmentEUR 850
  • UDI assignment and EUDAMED registrationEUR 1,300
  • Notified Body application packEUR 1,750
  • PMCF plan and PMS reportEUR 2,150
  • Final cross-reference and consistency checkEUR 2,600
  • Technical documentation assembly, Annex II and IIIEUR 4,350

The two add-on documents sit outside the Act price and are billed in addition where the device needs them.

Certification

An independent assessment of the regulatory system and the technical documentation, performed once the file is complete.

On a file without attested documents, 80 hours, EUR 28,500 excl. VAT.

Inside full service, where every document is already attested, 40 hours of the engagement.

Venitara Certification records an independent assessment of this organisation's regulatory system and technical documentation, performed by senior regulatory experts, setting out their assessment of concordance with the applicable regulatory requirements and of readiness for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, regulatory approval, a Notified Body certificate, or a guarantee of approval.

Attestation is expert review of a document you generated in the platform. The reviewer states what meets the requirement, what does not, and what specifically to change. Venitara does not rewrite the document.

The Venitara Attestation records that a named senior regulatory expert has reviewed this document against the Venitara rubric, and sets out their assessment of its concordance with the applicable regulatory requirements and its readiness for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, regulatory approval, a Notified Body certificate, or a guarantee of approval.

Ready to talk it through?

Both routes start with a short conversation that scopes your device, confirms the class and scope adjustments, and puts the figure in writing before anything is billed.
Talk to us

This subscription covers one device. A second device needs its own subscription.

It renews until you cancel it. You can cancel at any time, and the tools stay open until the end of the period you have paid for.

If it ends, everything you have written and every document you have generated stays readable.

Read the commercial terms (opens in a new tab)