Medtech QA/RA services · Utrecht
ISO 13485 audits and MDR gap assessments for medtech.
Two certified lead auditors who have built QA/RA functions from the ground up. Internal audits, gap assessments and a fractional QA/RA lead for medical device companies. Start with a free 20-minute call.
Free · 20 minutes · no obligation. You leave with a clear first step.
Not sure who you need? Take the one-minute quiz
Where are you right now?
Pick your situation. We take it from there.
Every engagement starts with a free 20-minute call, and you get the scope and a fixed price in writing before any work starts.
Walk into your audit knowing what they will find.
- ISO 13485 internal audit
- Supplier audit
- Internal auditor course
Know exactly what to build, and in what order.
- MDR and ISO 13485 gap assessment
- Fractional QA/RA lead
- Quality system workshop
Stop being the system your company runs on.
- Operations assessment and process mapping
- Workflow automation and document control
Know the regulatory truth before you invest.
- Regulatory and quality due diligence
- Portfolio readiness assessments
Prices exclude VAT. Not sure which fits? Take the one-minute quiz or book a free call.
What happens on the call
Twenty minutes. No obligation. A clear first step.
Take the quiz or pick a slot directly. It takes a minute.
You tell us where you are, we tell you what we would do first.
If there is a fit, a short proposal with the scope, the dates and a fixed price.
Also from Niavicta · our software, in development
nianav OS: one system for how a regulated company runs.
Alongside our QA/RA work, we are building the software we always wanted as quality leads: processes, records and evidence in one connected system, so audit-readiness comes from the work itself. It is not for sale yet. We are building it with a small group of design partners.