What you agree to when you buy

The two sides

These terms are between your company and Mangold Consultants, sole proprietorship of Niko Mangold (Freiberufler), which operates Venitara. Where these terms say we or us, they mean that business.

Business address: Kirchbergstraße 20, 64625 Bensheim, Germany. Owner: Niko Mangold. Mangold Consultants is not entered in a commercial register, so it has no registration number. Value added tax (VAT) identification number: DE450562852.

Anything to do with these terms, including a cancellation or a complaint about a review, reaches us at contact@venitara.com.

Business customers only

Venitara is offered to companies developing medical devices or placing them on the market, and these terms are written for business customers. We do not offer it to a person buying for private purposes.

We sell only to businesses within the meaning of section 14 of the German Civil Code (Bürgerliches Gesetzbuch, BGB), which means a person or company acting in the exercise of its trade, business, or profession. Every purchase asks you to confirm that you are buying for your business and that you accept these terms, and we do not start a purchase without that confirmation.

Drafting, review, and the marking that separates them

Venitara gives you tools that draft the documents an EU medical device file needs, and a route to have those drafts reviewed by a senior regulatory expert. You can buy the drafting, the review, or both.

Every piece of work carries a marker that says which one produced it. Work that has only been through the tools is marked AI-generated, not validated. Work a senior regulatory expert has reviewed is marked Expert-reviewed, with the reviewer named and the date recorded. A subscription buys the drafting, and a document produced under it alone keeps the first marker until a review is bought.

The third level, Certify, is human-led. It runs under a separate written agreement, and these terms do not govern it.

What we do not decide

Conformity with the Medical Device Regulation is assessed by a notified body, and Venitara is not one. Nothing you buy here is a conformity assessment, an endorsement by a notified body, a regulatory pre-approval, or a promise that any authority or notified body will accept your file.

We commit to the quality of the work we do. We make no commitment about a regulatory outcome, because that decision belongs to a notified body or a competent authority.

You remain the manufacturer. The responsibilities the Medical Device Regulation places on a manufacturer stay with you, and the person who signs your declaration of conformity is you.

One subscription, one device

A subscription opens the Venitara tools for one device file. Everyone in your company account can work on that device file for as long as the subscription runs, and we do not charge per person.

A second device needs a second subscription, at the same price. There is no multi-device discount today.

Price and renewal

The list price is EUR 349 per month excluding VAT, or EUR 3,799 per year excluding VAT paid in advance.

A monthly subscription renews each month, and an annual one renews each year, until you cancel it.

If we change our list prices, we do not raise the price of a subscription that is already running. A change applies to subscriptions started after it.

The free tools and the free window

When your company account is created, Intended Purpose and Classification are open at no charge for 14 days, counted from the day the account is created.

Every other tool needs a subscription from the start. The free window does not open them.

The MedTech Compass is free, is not part of the free window, and does not expire.

What happens when the free window ends

We take no card for the free window, and nothing is charged when it ends. When it ends, Intended Purpose and Classification close until you subscribe, and everything you have already written stays readable.

The free window is once per company. Adding a second device does not start another one.

Companies whose account existed before the free window was introduced keep Intended Purpose and Classification with no time limit.

Your first month of the subscription is free

The first subscription your company takes out starts with 30 days at no charge, whether you take it out during the free window or after it has ended. The first payment is taken at the end of those 30 days, and the subscription then renews as set out above.

You can cancel during those 30 days and nothing is charged at all.

The free 30 days are once per company. A second device, or a subscription taken out again after one has ended, starts charging from the first day.

What one review covers

An expert review is bought for one document or one output. A senior regulatory expert reads the draft, writes review notes, and the result is marked Expert-reviewed with the reviewer named and the date recorded.

A review is a review of the work you have done on that document. It does not extend to the rest of your file, and it does not transfer any manufacturer responsibility to us.

The turnaround we commit to

We quote 24–48h for an expert review, and that quote is the commitment. The review notes reach you within the quoted turnaround, counted from the point at which we confirm the request rather than from the moment you press the button.

The turnaround is counted on business days, Monday to Friday, in Central European Time, excluding public holidays in the German state of Hesse.

If we miss it, you can ask for one further expert review at no charge, on the same device. If we have delivered nothing at all after five business days, you can cancel the review and we refund it in full.

That credit is offered in addition to your rights under the law. It replaces none of them, and nothing in these terms limits a right you hold that cannot be limited by agreement.

Cancelling a subscription

You can cancel a subscription at any time. Cancellation takes effect at the end of the period you have already paid for, and the tools stay open for that device until then.

A period that has already started is not refunded in part, because your access runs to the end of it. An annual subscription cancelled part way through runs to the end of the year you paid for.

Cancelling a review

An expert review you have bought and that has not started is refunded in full if you cancel it. Once review notes have been delivered for a document, the fee for that document is earned.

Where a payment was taken in error, or for something we could not deliver at all, we refund it.

Your statutory rights are unaffected by anything in this section.

What survives the end of a subscription

The device file you build in Venitara is yours. The answers you enter, the history of changes, and every document generated from them stay readable to your company after a subscription ends or a free month runs out.

What ends is the ability to run the tools and generate new documents for that device. Nothing is deleted or hidden when access ends.

You can export the documents you have generated at any time while your account is open.

Ownership

The content you enter stays yours, and we claim no ownership of it. The tools themselves, the document templates, and everything we have built stay ours.

Every price is net

Every price we show is net and excludes VAT. VAT is added where it applies.

Government fees, notified body fees, and any other third party charges are not included in a Venitara price.

A price shown as a floor, in the form from a figure, is scoped with you before anything is charged.

How payment is taken

Payment is by card through our payment provider, or by invoice where we have agreed that with you in writing.

No availability commitment

We do not commit to a level of availability for Venitara. It can be unavailable during maintenance or because of an outage, and no credit or refund is given for the time it is unavailable.

Your statutory rights are unaffected by this section.

How far we are liable

We are liable without limitation for damage we cause intentionally or through gross negligence, for injury to life, body, or health, under the German Product Liability Act (Produkthaftungsgesetz), and under any guarantee we have given.

For damage we cause through slight negligence, we are liable only where we breach an essential contractual obligation. An essential contractual obligation is one whose fulfilment makes the proper performance of the contract possible in the first place, and on whose fulfilment you may regularly rely. In that case our liability is limited to the damage that was foreseeable when the contract was concluded and that is typical for a contract of this kind.

Apart from these cases, our liability is excluded.

What we do not guarantee

Venitara attests submission readiness and never certifies conformity. We do not guarantee any regulatory, notified body, or authority outcome.

Where personal data is covered

These terms do not describe how we handle personal data. For that, see the portal's privacy page.

Open the privacy page

Certify engagements

A Certify engagement is a separate written agreement, scoped for the device and signed before the work starts. These terms do not govern it.

Anything we have signed

Where we have signed an order form or an engagement letter with you, that document takes precedence over these terms for the work it covers.

Notice before a change applies

We may change these terms for the future. Where a change would apply to a subscription you are already running, we tell you at least thirty days before it takes effect, and you can cancel before it applies.

Law and place of jurisdiction

These terms are governed by the law of the Federal Republic of Germany, excluding the United Nations Convention on Contracts for the International Sale of Goods (CISG).

The place of jurisdiction for disputes arising from these terms is Bensheim, Germany, for customers who are merchants, legal persons under public law, or special funds under public law.

Language

These terms are written in English, and the English version is the one that governs. No German version has been published yet.