HealthSeed and Mangold Consultants introduce Venitara, a regulatory platform for medical device companies
Venitara is built for medical device, SaMD, and IVD companies that have no regulatory function of their own, pairing AI tools for the groundwork with senior experts who review the file and attest to its submission readiness. Prices and scope for each service are published at venitara.com/pricing.
Joint news release from HealthSeed AG and Mangold Consultants, first published on venitara.com on 15 September 2026.
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. It 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 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, and a manufacturer with an existing file can engage Venitara to review that work directly.
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. The tools support drafting, gap identification, and consistency checks across the file. AI-generated working documents are marked as unreviewed and unsuitable for submission until the appropriate review has been completed, and AI-only access provides working guidance and drafts without 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 and independent assessment of the regulatory system and complete technical file by senior experts who did not author the documents, whose 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 its regulatory documentation.
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 are at venitara.com/pricing.
HealthSeed AG and Mangold Consultants are the intended equal shareholders of the joint venture company, whose incorporation in Germany is in progress. Mangold Consultants contributes regulatory expertise and the platform, and HealthSeed AG contributes commercial strategy and market development. Niko Mangold leads the regulatory practice and product, 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 with 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 works with healthcare, biotech, and medtech companies on European market entry, regulatory and reimbursement strategy, and commercial execution, and builds ventures with technology partners whose products are ready for European markets but lack the commercial infrastructure to reach them. HealthSeed was co-founded by Daren Wilson and Safia Agueni.
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
Venitara: Niko Mangold, niko@venitara.com, +49 170 527 5221.
HealthSeed AG: Daren Wilson, Co-Founder and Senior Partner, daren.wilson@healthseed.vc, +41 76 680 8887.
Operating entity: Mangold Consultants, Kirchbergstrasse 20, 64625 Bensheim, Germany. Venitara is its business designation pending incorporation of the joint venture company.