I help medical-device and pharma companies build quality systems that pass audits and inspections, without burying their team in paperwork.
I work with SMEs and start-ups to set up a QMS that meets the standard and holds up for a notified body or inspection. I also do the reverse: bringing overgrown systems back to something clear and fast. And I audit your QMS to find the gaps before someone else does.
Seven years in quality took me through ISO 13485, ISO 14971, EU MDR, GDP and ISO 9001: complaint handling, post-market surveillance, supplier management and audits, document control and full implementations. That breadth means I see how the whole system fits together, not just how it reads on paper. I'm a certified lead auditor and CAPM certified in project management.
Why I went independent
I kept seeing the same problem: companies, large and small, buried under quality systems so bloated they slow everyone down. I wanted to fix that by designing systems that stay simple.
How I work
Hands-on and pragmatic. I don't sit in meetings to look busy; I get things done. A QMS should be as lean as possible, with procedures written as clear, step-by-step instructions a reader can follow effortlessly. I use AI to speed up the heavy lifting (drafting, cross-checking and gap analysis), while every judgment call and final review stays with me.
I'm based in Belgium and work with clients across the EU. Whether you're starting a QMS from scratch or fixing one under deadline, let's talk.