Legal notice

Impressum

Angaben gemäß § 5 Digitale-Dienste-Gesetz (DDG)

Operator of this website

Mangold ConsultantsInhaber: Niko MangoldKirchbergstraße 2064625 BensheimGermany

Contact

Email: contact@venitara.comTelephone: +49 170 5275221

VAT identification number

Umsatzsteuer-Identifikationsnummer gemäß § 27a Umsatzsteuergesetz: DE450562852

Professional status

Mangold Consultants is operated by a freelance professional (Freiberufler) under German law. The services offered through this website require no official authorisation, so no supervisory authority is named under § 5 para. 1 no. 3 DDG.

Responsible for editorial content

Verantwortlich für den Inhalt nach § 18 Abs. 2 Medienstaatsvertrag (MStV):

Niko Mangold, Kirchbergstraße 20, 64625 Bensheim.

About the company being formed

Venitara GmbH is a German limited liability company in formation. It is a joint venture of HealthSeed AG, Zurich, and Mangold Consultants, Germany.

Venitara GmbH is not yet entered in the Handelsregister and does not yet trade. Contracts concluded before registration are concluded with the operator named above.

Regulatory status

What Venitara is not

Venitara is a regulatory consultancy and software provider. It is not a Notified Body, it holds no designation under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, and it is not a competent authority, a certification body, or an accreditation body in any jurisdiction.

Venitara does not carry out conformity assessment, does not grant marketing authorisation, and does not submit on a manufacturer's behalf or attend a manufacturer's audit. Those acts belong to the manufacturer, to a designated Notified Body, or to a competent authority.

Venitara issues its own assessment artefacts, the Venitara Attestation and the Venitara Certificate. Neither is a certificate of conformity within the meaning of Regulation (EU) 2017/745 or Regulation (EU) 2017/746. Neither is issued by or on behalf of a Notified Body, and neither confers or evidences the right to place a product on any market. Each records the assessment of named Venitara experts, within a stated scope, on a stated date.

No activity offered through this website requires official authorisation in Germany, so no supervisory authority is named under § 5 para. 1 no. 3 DDG. Venitara is not a regulated profession within the meaning of § 5 para. 1 no. 5 DDG.

The two artefacts and their bound disclaimers

Venitara issues two assessment artefacts, each with its own seal and its own bound disclaimer. The Attestation seal marks a document at Attest. The Certification seal marks the certificate at Certify. Each disclaimer travels with its artefact, verbatim and visible on load, wherever the artefact or its seal appears.

The Venitara Attestation. 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.

Venitara Certification. 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.

Assurance levels and what each output claims

Venitara delivers at three assurance levels. The level attached to an output sets what that output can be relied on for.

• Explore. Generated automatically from the answers a customer supplies, by fixed rules or by artificial intelligence depending on the tool. Not reviewed by a regulatory expert. Not suitable for submission. It is an indicative readiness map, never a determination of a product's regulatory classification or legal status.
• Attest. A named senior regulatory expert reviews a document, records what holds, the version read, and the date, and issues the Venitara Attestation under the Attestation seal.
• Certify. Senior Venitara experts assess the organisation's regulatory system and the complete technical file for submission readiness. They issue the Venitara Certificate under the Certification seal, within a stated scope and on a stated date. Certification includes an attestation on every document inside the scope assessed.

Nothing produced at any level is legal advice, and none of it transfers the manufacturer's obligations under the Medical Device Regulation, the In Vitro Diagnostic Regulation, or any equivalent regime. The manufacturer remains responsible for its device, its technical documentation, and its declarations.

Independence and interests

Venitara sells assessment, so it discloses its interests specifically rather than describing them in general terms.

Venitara is co-owned by HealthSeed AG and Mangold Consultants. HealthSeed AG provides commercialisation and market access services to healthcare companies, and a customer of one may be a customer of the other. The two companies contract separately, and engaging Venitara creates no obligation to engage HealthSeed AG.

A member of Venitara's senior regulatory team previously held an assessor credential with a conformity assessment body. That person holds no assessment role today and takes no part in assessing any Venitara customer's file. The body is not named here.

Where a conflict cannot be managed, Venitara declines the engagement and says so.

Content and liability

Accuracy of content. This website gives general information about Venitara and about medical device regulation. Regulation changes, and how it applies depends on the specific product, its intended purpose, and the market. We take care to keep the content accurate and current, but we give no warranty that it is complete, accurate, or current. Nothing on this website is legal, regulatory, clinical, or financial advice, and nothing on it creates a client relationship. Decisions about a regulated product should be taken on advice that addresses that product.

Liability. To the extent permitted by law, we accept no liability for loss arising from reliance on the content of this website. This limitation does not apply to liability for death or personal injury, for intent or gross negligence, for breach of a material contractual duty, or under the German Product Liability Act. It does not limit any liability that cannot be limited by law.

Liability for links. Where this website links to external sites, we have no control over their content and accept no responsibility for it. Links were checked for unlawful content when they were set. Responsibility for linked content rests with its operators, and we will remove a link promptly if we are told of an infringement.

Copyright. The content of this website is protected by copyright and other rights. This includes the text, graphics, logos, both seals, the design system, and the underlying document templates. It belongs to the operator named in the Impressum, to the Venitara joint venture partners, to the entity that holds the Venitara intellectual property, or to their licensors. It may not be copied, adapted, or made available to the public without our prior written permission. Reproduction of any Venitara artefact or seal, in whole or in part, outside the terms on which it was issued is prohibited.

Trade marks. Venitara, the Attestation seal, the Certification seal, the Venitara Attestation, and the Venitara Certificate are used as brand identifiers. Trade mark applications have been filed, and no registered rights are asserted until registration. Third-party marks named on this website belong to their owners.

Artificial intelligence. Parts of this website and of the Venitara platform produce content generated by artificial intelligence, and that output is marked. Content marked as AI-generated and not validated has not been reviewed by a regulatory expert and should not be relied on as a determination of any regulatory question.

Dispute resolution

Venitara's services are offered to businesses. We are not obliged to take part in dispute resolution proceedings before a consumer arbitration body under the German Consumer Dispute Resolution Act, and we do not do so voluntarily.

Governing law

German law applies to this website and to its use, excluding the conflict of law rules. The courts at the operator's seat in Bensheim, Germany, have jurisdiction. Mandatory consumer protection in a customer's country of residence is unaffected.

Contact

Mangold ConsultantsKirchbergstraße 2064625 BensheimGermanycontact@venitara.com