ISO 13485 audits, MDR gap assessments and fractional QA/RA for medtech.Book a 20-minute call ›
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Training

Training taught by practising lead auditors.

In-company courses for your team or your incubator cohort. Built around your own procedures, taught by people who run these audits every year.

Internal auditor course €5,950 per group of up to 8. Workshop €1,450 per group. In English or Dutch.

Book a call about training What you get

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

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

Who it is for If one of these sounds familiar, a 20-minute call is worth it.
Quality teamsYou need trained internal auditors for your ISO 13485 or ISO 9001 audit programme.
Founders and early teamsYou know you need a quality system and want to understand it before you build it.
Incubators and acceleratorsYou want every medtech company in your cohort to start with the same foundation.
New quality hiresSomeone has just joined your quality team and needs to be effective fast.
What you get Scope, deliverables and price in writing before any work starts. Prices exclude VAT.
Two-day course

ISO 13485 or ISO 9001 internal auditor course

€5,950per group of up to 8 · two days, in-company

For quality teams who need trained internal auditors.

  • Day 1: the standard, the audit programme and how to plan an audit
  • Day 2: running the audit, writing findings with objective evidence, reporting
  • Practice on your own procedures
  • A certificate of completion for your training records
Book a call about the course
Half-day workshop

Your quality system in plain language

€1,450per group · half day

For founders and early teams building their first quality system.

  • What ISO 13485 and the MDR ask of you, in plain words
  • What to build first, and what can wait
  • The mistakes that cost start-ups months
  • Time for your own questions
Book a call about the workshop
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

Both founders teach. Jasmine Beukema has built and trained QA/RA teams at executive level for close to twenty years, and teaches in English or Dutch. Chani Galgut is a CQI/IRCA certified ISO 13485 lead auditor who turns the standard into practice your team can use the next day.

Questions The ones people ask on the first call.
Is the certificate an accredited qualification?

No. You receive a certificate of completion for your training records. It shows competence for your internal audit programme, and it is not an accredited lead auditor qualification.

Online or in person?

Both. Most groups prefer in person at their own office, and we also teach online.

In which language?

English or Dutch.

Can you tailor it to our company?

Yes. We build the exercises around your own procedures, so your team practises on the real thing.

Also from Niavicta: Services and pricesSupplier auditsOperations and systemsInvestors and incubatorsISO 13485 internal audits

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.

Book a call about training All services and prices