Niavicta runs internal audits, regulated audit readiness, systems implementation, and management consulting for teams that need work to run without them. Regulated or not. You keep working the whole time.
We run it as a formal internal audit against your standard, not a light opinion. You get documented findings, the objective evidence behind each one, and a clear route to close.
ISO 13485 requires internal audits on a schedule. We run them for you, every year, whether or not you build anything else with us. Full detail on what we audit is below.
Both founders hold the CQI/IRCA Certified Lead Auditor qualification for ISO 13485:2016, backed by MDR, MDSAP, and clause-by-clause training, and years of hands-on QA/RA inside regulated medtech.
We run it properly: a documented audit plan and programme, full scope against the clauses, and we get trained on your own internal audit procedure first, so the audit is done to your process, not a generic checklist. We arrive with the competency and independence evidence your certification body will ask to see, so your internal audit holds up when they audit it.
And if you are the QA reading this: we know. We have been you, the one holding the whole system together the week before an audit. We have sat through the same ones you have, so we know what the external auditor reaches for when they open your internal audit file, and we make sure it is already waiting for them.
Our full certifications, courses, and competency evidence are listed at the foot of this page, available for your QA or notified body on request.
Regulated teams get the audit depth and the compliance built in. Everyone else gets a company that runs itself instead of running through one or two people and a stack of spreadsheets.
If your business still lives in your head and your inbox, this is for you.
The engagement runs in four phases: diagnose, map, build, hand over. Each one ends in something complete and useful on its own.
Take only the diagnostic. Take the map to your own team. Or have us build the whole thing and hand it back. You decide at every gate.
We can implement the automations ourselves, taking the manual, repeated work off your desk. Or, if you have an internal team, we hand them a map clear enough to build from.
Your first working automation goes live early in the engagement, not at the end.
We work with your team a couple of days a week. The business keeps running. When we leave, the system runs without us, and your people know how to keep it that way.
For an internal audit: you tell us the scope you have in mind, a single day or several, and we build that into the audit plan and the quote up front. The fee and the dates are fixed before we start.
For a larger build: the first call sizes your company and sets the diagnostic. From there, each phase is scoped, priced, and dated at its gate, and nothing moves forward until you have agreed both.
Every phase carries a fixed fee. No open meter, no surprise invoice. You always know the cost and the timeline before you commit.
You get: a written diagnostic report and a one-page map of how the work really moves, with the first jobs worth fixing named in order.
Regulated? The diagnostic includes a full internal audit against your standard, run by a certified lead auditor.
You get: the target design and a prioritised fix list, laid out so any competent team could build from it. The whole garden, drawn.
You get: working automations that take the manual, repeated, error-prone jobs off your desk. Your first one goes live early, not at the end.
You get: a trained team and the documentation to keep it running. The system belongs to you, and it holds when we leave.
You have a standard to hold: ISO 13485, ISO 9001, or EU MDR. We run a formal internal audit against it, then map and build the fixes. The audit is real evidence you can put in front of a notified body.
What we audit › Medtech internal audit page ›No standard to answer to, just a company running through too few people. We diagnose how the work really moves, map the target system, and build it. The same discipline, without the audit machinery.
How we work ›An internal audit is only worth what the auditor is. Both founders are CQI/IRCA certified ISO 13485 lead auditors, with hands-on QA/RA experience across regulated medtech, not classroom-only credentials.
We audit as independent internal auditors: documented findings against the clause, the objective evidence behind each one, and a route to close. Our competency evidence is available on request, the way a notified body or a customer's QA would expect.
Every phase has a fixed fee agreed before it starts. You always know what you are spending and exactly what you get for it.
The diagnostic is what makes this safe. It measures the size of the job, so the price for the map and the build is quoted from what is really there, never a guess.
Anything outside an agreed phase is quoted as its own phase, so a fixed price stays fixed. You commit one phase at a time and decide at each gate whether the next one is worth it.
One conversation tells us whether this fits. The diagnostic tells you where you stand and what to fix first.