HealthSeed AG and Mangold Consultants introduce Venitara, a regulatory platform combining AI regulatory tools and expert services

Venitara AI tools help teams map their regulatory pathway, draft technical documentation and identify gaps. Senior regulatory experts at Venitara create, review and validate regulatory documents, and provide written attestations of submission readiness.

Companies can choose AI tools alone, AI with expert support, or regulatory expert services without using the AI platform.

Zurich, Switzerland and Bensheim, Germany, 15 September 2026. HealthSeed AG, a Swiss healthcare venture studio, and Mangold Consultants, a German medical device regulatory consultancy, today announced Venitara, a regulatory platform and expert service for medical device companies, including developers of software as a medical device (SaMD) and in vitro diagnostics. Venitara supports regulatory planning, documentation and preparation for submission across the European Union, the United States and selected Middle East and North Africa markets. Venitara is built for companies without an in-house regulatory function, from a first submission through to MDR transition and lifecycle maintenance.

Venitara combines AI tools for regulatory planning and documentation with separately available expert services and a documented assessment of submission readiness. Customers can build their own working file, ask an expert to prepare or review selected documents, or commission a broader assessment of their regulatory system and complete technical documentation. Expert support can be added to existing work without requiring a platform subscription.

This allows the level of support to match the team's experience, the work already completed and the decisions ahead. A company establishing its regulatory pathway can start with AI guidance. A team preparing evidence can hand a specific deliverable to an expert to draw up. A manufacturer with an existing file can engage Venitara to review that work directly.

"We priced the answer separately from the project, so a company can buy an expert read on the one document that is keeping them awake," said Niko Mangold, founder of Mangold Consultants and chief executive designate of Venitara.

The platform holds one connected product record covering intended purpose and claims, classification rationale, risk management, clinical and performance evidence, quality-system records, technical documentation and post-market planning. Because each fact is held once, a change in one place shows what has to be reviewed with it. Its tools support drafting, gap identification and consistency checks across the file. AI-generated working documents are clearly marked as unreviewed and unsuitable for submission until the appropriate review has been completed. AI-only access provides working guidance and drafts; it does not include expert assurance.

When a senior regulatory expert assesses a document as ready for submission, the Venitara Attestation records the reviewer, the document version, the assessment criteria and the date. Customers can also commission Venitara Certification, a broader, independent assessment of the regulatory system and complete technical file by senior experts who did not author the documents. Its certificate records submission readiness within a stated scope.

Venitara's attestations and submission-readiness certificates are not regulatory approval, conformity assessment or Notified Body certificates, and they do not guarantee approval. The manufacturer retains responsibility for its device and regulatory documentation.

"A founder does not want to become a regulatory professional," said Daren Wilson, co-founder of HealthSeed AG and chief operating officer designate of Venitara. "They want to know where the file stands, what is due now, and what it costs, and the last of those has been close to unanswerable in this market. Our prices are on the website. So is the list of what we will not do."

Venitara offers a free MedTech Compass assessment, which provides an indicative device classification, route to market and gap list in about ten minutes. Paid platform access covers the working product record, AI tools and documentation. Expert services are purchased separately by stage or agreed scope, and can cover drawing up documents as well as reviewing files prepared by the customer or another provider. Published prices and scope information are available at venitara.com/pricing.

Venitara is designed to support regulatory submissions in the European Union, the United States and selected Middle East and North Africa markets, with one connected file behind each of them.

"The Gulf and North Africa cannot be treated as one regulatory market, or as an extension of Europe," said Safia Agueni, co-founder of HealthSeed AG and Head of Partnerships designate at Venitara. "Across the region, regulators and health systems are strengthening their own evidence, data and sovereignty requirements, while moving at very different speeds. For manufacturers, the challenge is not simply to reuse a European file, but to build an evidence and regulatory strategy that can travel with the right local adaptation. Venitara is designed to make that possible, so MENA expansion is considered from the outset rather than added once the European work is already finished."

HealthSeed AG and Mangold Consultants are equal shareholders of the joint venture company. Mangold Consultants contributes regulatory expertise and the platform; HealthSeed AG contributes commercial strategy and market development. Niko Mangold leads the regulatory practice and product, while Daren Wilson leads operations and commercial development and Safia Agueni leads partnerships.

Companies can start the free MedTech Compass assessment or discuss expert support at venitara.com.

Questions about the launch are answered in the companion FAQ.

About Venitara

Venitara is a regulatory platform and expert service for medical device, SaMD and in vitro diagnostic companies. It combines AI tools for regulatory planning and documentation with senior regulatory experts who draw up and review that documentation, and documented assessments of submission readiness. Customers can use the AI platform independently, add expert support, or engage regulatory experts without a platform subscription. Venitara currently operates under Mangold Consultants pending incorporation of the joint venture company in Germany. venitara.com

About HealthSeed AG

HealthSeed AG is a Swiss healthcare venture studio and commercialisation partner. It supports healthcare, biotech and medtech companies with market entry, commercial strategy and execution, and builds ventures with technology partners. HealthSeed was co-founded by Daren Wilson and Safia Agueni. healthseed.vc

About Mangold Consultants

Mangold Consultants is a German medical device regulatory consultancy founded by Niko Mangold. It contributes its regulatory practice, delivery tools and client platform to Venitara. mangold-medtech.com

Media contact

Niko Mangold | niko@venitara.com | +49 170 527 5221

Operating entity: Mangold Consultants, Kirchbergstrasse 20, 64625 Bensheim, Germany. Venitara is its business designation pending incorporation of the joint venture company.