ISO 13485 audits, MDR gap assessments and fractional QA/RA for medtech.Book a 20-minute call ›
Niavicta nianav OS
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For investors and incubators

Know where a medtech company stands before you invest.

Independent regulatory and quality due diligence on medtech companies, and readiness assessments for your whole portfolio. In plain language, with the cost and time to close every gap.

Due diligence from €4,950 per company. Portfolio assessments from €950 per company.

Free · 20 minutes · no obligation. You leave with a clear first step.

Not sure who you need? Take the one-minute quiz

When you need it If one of these sounds familiar, a 20-minute call is worth it.
Before a term sheetYou are looking at a medtech company and want the regulatory picture before you commit.
Before an acquisitionYou want to know what the certificates, files and quality system are really worth.
Across your portfolioYou run an incubator, accelerator or fund and want every medtech company on a clear path to market.
When a timeline slipsA portfolio company says its CE mark is "six months away", again.
What you get Scope, deliverables and price in writing before any work starts. Prices exclude VAT.
Due diligence

Regulatory and quality due diligence

from €4,950per company · timed to your deal

For VCs, angels and acquirers looking at a medtech company.

  • The regulatory pathway, device class and certificates
  • The technical documentation and its gaps
  • The quality system and the evidence behind it
  • What each gap will cost in time and money to close, in a report for your investment committee
Portfolio readiness

Readiness assessments for your portfolio

from €950per company · for a cohort or fund

For incubators, accelerators and VCs with several medtech companies.

  • A short regulatory and quality assessment per company
  • Each company ranked on readiness, with its next three steps
  • An overview for the programme or fund
  • Optional workshops for the cohort
How it works Four steps, and you know the price at the second one.
01Book a free call

Twenty minutes to understand where you are and what you need.

02Scope and price in writing

A short proposal with the scope, the dates and a fixed price.

03We do the work with you

On site or remote, alongside your team, so nothing stops.

04Report and next steps

A clear report, a read-out, and the next steps in priority order.

Who leads it The founders do the work themselves.
Jasmine Beukema, co-founder of Niavicta

Jasmine Beukema leads investor work. She spent close to twenty years in QA/RA leadership, including as VP QA/RA at Sophia Genetics and Vitestro, and steered the world's first fully autonomous robotic medical device through CE marking and FDA De Novo. She knows what a regulatory path costs, because she has walked it. Chani Galgut joins on quality systems and operations.

Questions The ones people ask on the first call.
Is the work confidential?

Yes. We sign your NDA before we see anything, and the report goes only to you.

Do you speak to the founders?

With your permission, yes. A short interview with the founders and their quality lead usually tells us more than the documents alone.

Are you independent?

Yes. We have no stake in the companies we assess, and we tell you up front if we have ever worked with one of them.

How fast can you turn it around?

We time the work to your deal. Tell us the date on the first call and we scope to it.

Twenty minutes tells you where you stand.

Book a free call. You leave with a clear first step, whether or not you work with us.