ISO 13485 internal audit
€1,200per auditor day · usually 2 to 3 days
Find the gaps before your notified body does.
- Audit plan agreed up front
- Graded findings with objective evidence
- A CAPA-ready report
Medtech QA/RA services
Quality and regulatory help for medtech.
ISO 13485 internal audits, MDR gap assessments and a fractional QA/RA lead, from two certified lead auditors who have built QA/RA functions from the ground up. 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
certified ISO 13485 lead auditors
Chani GalgutLead auditor · QA/RA 
Jasmine BeukemaLead auditor · QA/RA
Lead auditors do the workThe two founders, every time. Never handed to a junior.
Fixed price, in writingScope, dates and price agreed before any work starts.
Findings with evidenceGraded, clause by clause, and ready for your CAPA process.
English or DutchOn site across the Netherlands and the EU, or remote.
Where are you right now?
Pick the one that fits. Every price excludes VAT and is confirmed in writing before any work starts.
Walk into your audit knowing what they will find.
For companies with a notified body, certification or supplier audit coming up.
Supplier and contract-manufacturer audit
€1,200per auditor day · usually 1 to 2 days
Prove you control the suppliers your device depends on.
- On site or remote, against ISO 13485
- A supplier risk rating
- A report ready for your supplier file
Internal auditor course
€5,950per group · two days, up to 8 people
Train your own team to run the audits.
- ISO 13485 or ISO 9001
- Practice on your own procedures
- In English or Dutch
Know exactly what to build, and in what order.
For start-ups working towards a CE mark or a first certification audit.
Your quality system in plain language
€1,450per group · half day
Understand what the rules ask before you build anything.
- ISO 13485 and the MDR in plain words
- What to build first, and what can wait
- Time for your own questions
MDR and ISO 13485 gap assessment
€4,950fixed · one week, kickoff to read-out
See exactly where you stand, and the fastest route to certification.
- A gap register with the clause behind every gap
- Findings ranked by risk
- A 90-day roadmap to readiness
Fractional QA/RA lead
from €3,000per month · from two days a month
Senior QA/RA leadership before you can hire it.
- Management review, CAPA and supplier oversight
- Audit preparation
- Your team coached so the knowledge stays
Stop being the system your company runs on.
For growing companies that run on a few people, spreadsheets and inboxes.
Operations assessment and process mapping
from €2,950fixed per phase · stop after any phase
See how the work really flows before you fix it.
- How the company runs today, documented
- Key processes mapped with owners
- A plan for what to fix first
Workflow automation and document control
from €3,500per build · handed over to your team
Take the repeated manual work off your team's desk.
- Automations in Microsoft 365 and Power Automate
- Document control people actually use
- A first automation live early
Know the regulatory truth before you invest.
For VCs, angels, acquirers, incubators and accelerators.
Regulatory and quality due diligence
from €4,950per company · timed to your deal
The gaps, and what they will cost to close, before the term sheet.
- Pathway, certificates and technical file
- Quality system and its evidence
- A report for your investment committee
Readiness assessments for your portfolio
from €950per company · for a cohort or fund
Every medtech company in your portfolio on a clear path to market.
- A short assessment per company
- Ranked on readiness, with next steps
- An overview for the programme
Not sure which fits? Take the one-minute quiz or book a free call and we will tell you.
What happens on the call
Free, 20 minutes, no obligation.
01Pick a time
Take the quiz or pick a slot directly. It takes a minute.
02Talk to a lead auditor
Twenty minutes on Teams. You tell us where you are, we tell you what we would do first.
03Get it in writing
If there is a fit, a short proposal with the scope, the dates and a fixed price.
Who does the work
The two founders, every time.
Chani Galgut
- CQI/IRCA Certified Lead Auditor, ISO 13485:2016
- Quality and compliance in regulated medtech, including Vitestro
- ISO 13485, EU MDR, MDSAP and FDA QMSR
Jasmine Beukema
- ISO 13485:2016 Lead Auditor, BSI
- 18 years of QA/RA leadership, former VP QA/RA at Sophia Genetics and Vitestro
- Built QA/RA functions from zero, with CE marking and FDA De Novo experience
- Leads our regulatory work: EUDAMED registration, technical documentation and regulatory strategy
Questions
The ones people ask on the first call.
What does a first call cost?
Nothing. The 20-minute call is free. You tell us where you are, we tell you what we would do first and whether we are the right people for it.
Are the prices fixed?
Yes. Before any work starts you receive the scope and the price in writing. Prices exclude VAT.
Who does the work?
The two founders, Chani Galgut and Jasmine Beukema. Both are certified ISO 13485 lead auditors with hands-on QA/RA experience in medtech.
Can a subsidy pay part of it?
Sometimes. Dutch startups can in some cases use a voucher, for example the LifeSciences@Work Value Voucher through MedTechPartners. Ask us on the call and we will check it with you.
Can you build our whole quality system?
Yes, as a scoped project after the gap assessment. The roadmap shows what it takes, and we quote the build as a fixed price.
Do you work on site or remotely?
Both. Internal audits usually include time on site, and most other work runs remotely with your team.
Twenty minutes tells you where you stand.
Book a free call with Chani or Jasmine. You leave with a clear first step, whether or not you work with us.