Who is accountable for the work, and how the company is built.

An experienced team who gets medical device, SaMD and IVD companies to market

Venitara pairs a regulatory professional who has taken more than forty devices through their approval routes and assesses technical files for a Notified Body, with an executive who has taken healthcare products to market across three continents.

The company exists because the two of them had been solving separate halves of the same problem for separate clients, and decided to solve it as one company instead.

Why Venitara exists

Regulation is the hardest part of building a medical device.

Most medical device founders meet regulation late. They have built something that works, and then discover that working is the smaller half of the problem. Run that across the European Union, the United States, and the Gulf, each with its own rules and its own evidence expectations, and it becomes the single hardest thing a small company does before it ever reaches a patient.

One end

AI-only tools

Fast and cheap, and no qualified person is accountable for what it produces.

The ground between

Venitara

Software carries the drafting and the consistency. A senior regulatory professional owns the judgement and signs the work. Alongside it sits the commercial side of the same problem, because a device that clears its approval route and cannot find a payer has solved half of what the founder needed.

The other end

Traditional consultancy

Genuine depth, at a price and a pace most companies at this stage cannot carry, and it leaves them holding a deliverable rather than an understanding.

What a founder ends up with is a technical file they own and understand, a named person who has stood behind the parts that carry risk, and a route to the patients and health systems the product was built for.

The people

Niko Mangold

Chief Executive Officer

40+ regulatory projects10–12 Notified BodiesAssessor credential

Niko has spent his career in medical device regulation, delivering more than forty regulatory projects and working in cooperation with ten to twelve Notified Bodies across the EU. He holds an assessor credential with QS International, which means he assesses technical files against the standard a Notified Body applies. That credential sits behind an independence firewall, so he takes no assessment role on any device Venitara has worked on.

He built the Venitara platform himself, starting from the documents he had written by hand too many times. He leads the company, its regulatory practice, and its product.

View Niko's profile on LinkedIn

Daren Wilson

Chief Operating Officer

Pharmaceutical leadershipEU · US · GulfHealthSeed AG

Daren spent his career in pharmaceutical leadership, including general management roles across several geographies, before founding HealthSeed AG, a Swiss healthcare venture studio. He works across commercialisation, market access, and the operating models that let a small company deliver at scale.

He runs Venitara's operations, its commercial strategy, and its market development across Europe, the United States, and the Gulf.

View Daren's profile on LinkedIn

How the company is built

Venitara is a joint venture of HealthSeed AG & Mangold Consultants.

Venitara operates out of Germany and serves clients across the European Union, Switzerland, the United States, and the MENA region.

Based in the European Union, Venitara can act as your EU Authorised Representative under the Medical Device Regulation, which is a role every manufacturer outside the Union needs before it can place a device on the market.

healthseed.vc mangold-medtech.com

What Venitara does not do

Three things we will not tell you.

Regulation attracts confident promises, and most of them are about decisions the promiser does not control.

Certify conformity.

Under Annex VII of the Medical Device Regulation, conformity is certified by a designated Notified Body and by nobody else. What we issue is an attestation: a written, independent assessment that your file has been brought to a submission-ready standard, measured against the criteria an assessor applies.

Submit on your behalf, or sit your audit.

You are the manufacturer, and those acts are yours.

Build and assess the same file.

Niko holds an assessor credential with QS International, and it sits behind an independence firewall. He takes no assessment role on any device Venitara has worked on, and Venitara takes no client whose file he is assessing. The credential tells you what standard we build to, and it buys your submission nothing.

Guarantee approval.

You should be careful with anyone who does. What we can do is materially improve the probability and the speed of it, by finding the gaps before your assessor does.

The regulatory route is long, and most founders walk it once. We have walked it more than forty times.

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