ISO 13485 audits, MDR gap assessments and fractional QA/RA for medtech.Book a 20-minute call ›
Niavicta nianav OS
Book a call
Follow the journey · Founder Diaries

I saw the same problem at every company, so I resigned.

Every company I audited had the same pattern: good teams, responsibility nobody wrote down, and a culture that soured. So I left to build the thing I wished each of them had.

Chani Galgut, founder of Niavicta
A team working together at a shared table, one person taking notes by hand

I have a degree in human physiology and psychology. Straight out of school I went into QA at a dental company. The manager there wanted someone with zero experience, on purpose, because she didn't want somebody to come in with new ideas and change the system that she had been building for years.

I took it because I had always wanted to come to Europe, and I realized this job could get me there. So I made a checklist. I looked at every vacancy in Europe I could find, and I wrote down what they all asked for: years of experience, managerial experience, a lead auditor course. That checklist became my plan.

From the dental company I moved to a brand label manufacturer, managing QA and RA across offices in the UK, Australia, and South Africa. It was a business role more than a technical one, mostly supplier management, and I noticed that the quality people and the business people spoke different languages. I decided to fix that in myself, and started a master's in international management part time, because the only way I was ever going to get anywhere was to speak the same language as the people who needed to understand me.

Six months in, I was fanatically applying to jobs overseas. I had a fixed amount of money and I gave myself a deadline: there was an ISO lead auditor course starting in three months, and whichever happened first, the overseas job or the course, that was the path I would take. At the same time, as a backup, I registered a shell company, a medical device consultancy, so that if the overseas move fell through I would do my lead auditor course and start consulting instead.

The overseas job came through first. I moved to the Netherlands to work at a company doing autonomous robotic phlebotomy in Utrecht. They use AI and ultrasound to find the vein in your arm and place the needle in exactly the right spot. I got to work with engineers again, and I loved it.

The whole time I was there, I was also doing supplier audits on the side. And across every single audit, I kept seeing the same thing. Teams start out nice to each other. Then, the moment responsibility, authority, and onboarding aren't properly documented, people stop being nice.

I think it comes down to purpose. People want to know why they're here and what they're actually supposed to be doing. And there's a real dichotomy here because nobody wants to document things, because it feels like extra work. But in medical devices, if you get something wrong, you know you'll get in trouble for it. So the fear is there anyway, undocumented, and it curdles the culture in a place where you spend more hours with these people than with your own family.

I realized it didn't matter which company I went to next. They were all going to have the same problem, because the problem was never really about the rules. Regulation isn't actually that hard. People just don't want to look at it, because it's scary. And even a state-of-the-art company (the kind that sends people to the moon, allegedly) is still running a QMS, a PLM, a CRM, and an HRIS that don't talk to each other, so the same information gets duplicated everywhere, by hand, forever.

Nobody seemed to be doing anything about that. At least, I hadn't heard of anyone who was.

So I resigned. And I started building the thing I wished had existed at every company I had ever worked for: one place where the org, the procedures, and the projects are the same living system, instead of six disconnected tools that all need to be kept in sync by a person.

That's Niavicta.