Can Niavicta run an ISO 13485 internal audit for a medtech company?

Yes. Niavicta runs ISO 13485 internal audits for medtech and regulated teams. Both founders are certified ISO 13485 lead auditors with hands-on QA and RA experience.

Where does Niavicta provide medtech internal audit services?

Niavicta is based in Utrecht and serves companies in the Netherlands and across the EU. Work can be scoped for onsite, remote, or hybrid audit activity depending on the system and evidence involved.

What does the internal audit deliver?

The audit deliverable includes an agreed scope, documented findings, objective evidence, and a route to close each issue so the output can support certification-body or notified-body review.

Which medtech areas does Niavicta understand?

Niavicta has experience across software as a medical device, health AI, autonomous devices, robotics, implantable devices, IVDs, chemistry, and combination products.

Medtech internal audit

ISO 13485 internal auditor for medtech companies in the Netherlands.

Niavicta runs ISO 13485 and ISO 9001 internal audits for medical device, health AI, IVD, robotics, and regulated teams. We are based in Utrecht and work with companies across the Netherlands and the EU.

Ask about an internal audit What you get

Direct answer: If you need a medtech internal auditor near you, Niavicta provides certified ISO 13485 lead auditor support from Utrecht for Netherlands and EU-based teams, with findings, objective evidence, and a route to close.

What you get An audit output your QA lead, certification body, or notified body can follow.

Audit plan and scope

We agree the standard, sites, processes, people, evidence sources, dates, and audit method before the audit starts.

Findings with evidence

Each finding is tied to the requirement, the observed objective evidence, and what needs to be closed.

CAPA-ready follow-up

The output is structured so your team can move from audit finding to correction, root cause, CAPA, and effectiveness review.

Who audits you Certified auditors with real regulated-device experience.

Not classroom-only auditors.

Both Niavicta founders are certified ISO 13485 lead auditors with hands-on QA and RA experience inside regulated medtech. We understand what an external auditor, notified body, customer QA team, or certification body reaches for when they open the internal audit file.

We audit medical device and medtech operating systems where the work actually happens: procedures, records, design control, supplier qualification, training, CAPA, change control, software, hardware, AI-enabled devices, IVDs, robotics, implantables, and combination-product environments.

Local fit Built for searches like internal auditor near me medtech.

Utrecht

Based in the Netherlands.

Niavicta is based in Utrecht and works with companies across the Netherlands, including Amsterdam, Eindhoven, Rotterdam, Leiden, Delft, and nearby medtech hubs.

Regulated context.

We are strongest where ISO 13485, ISO 9001, EU MDR, IVDR, FDA QMSR familiarity, MDSAP awareness, and practical operating evidence matter.

Hybrid

Onsite or remote scope.

Some audits need onsite process observation. Some can be scoped remotely. We agree the method up front so the audit remains defensible.

Questions The short answers Google and buyers need.

Can Niavicta run our ISO 13485 internal audit?Yes. We run formal internal audits for medtech and regulated teams.Detail

We agree the scope, audit plan, evidence sources, and method before we start. The output includes findings, objective evidence, and a route to close.

Are you near us?If you are in the Netherlands or EU, likely yes. We are based in Utrecht.Location

Niavicta is based in Utrecht and serves teams across the Netherlands and the EU. Work can be onsite, remote, or hybrid depending on the audit scope.

Do you only audit, or can you help close the gaps?Both. The audit can stand alone, or lead into mapping and implementation.Next step

Some clients only need the internal audit. Others want the gaps mapped into working procedures, records, systems, and handover. We scope that separately so the audit stays independent and clear.

Related More context for regulated teams.

Service