At MedQAIR, we’re proud of the people who make our mission possible. Each team member brings a unique blend of experience, perspective, and commitment to improving how medical device companies approach regulatory and quality affairs. Today, we introduce Trudy Kunnen, Principal Consultant at MedQAIR, whose career journey has taken her from computer science and software engineering into leadership roles in quality and regulatory affairs, and now into MedQAIR’s fast-moving, collaborative environment.
With years of experience at Philips Healthcare and beyond, Trudy has built and managed Quality Management Systems, led cross-functional teams, and guided organizations through complex regulatory transitions. Her background bridges technical expertise and regulatory leadership, which makes her a valuable partner for manufacturers navigating the challenges of MDR and SaMD compliance.
In this interview, Trudy shares how she found her way into regulatory affairs, what she has learned from building bridges between technical and quality teams, and why she believes platforms like MDIS can bring much-needed structure to today’s compliance challenges.
1. Could you briefly introduce yourself and your professional journey so far?
Born and raised in the Eindhoven area, attending my studies at Eindhoven University of Technology was logical as it allowed me to continue my social and sportive life at home. My choice for Computer Science was driven by the promise of ample opportunities once mastered. After graduation, becoming a software engineer was a logical first step. However, the vacancy market was grim at that time. Luckily, I was offered a short-term position as a researcher at the Eindhoven University, which allowed me time to develop a better picture of what type of company and position would fit me, and for which company I would be a good fit.
Philips Healthcare was a match, and I indeed started there the first couple of years as a software engineer. Working for a larger company means you get the opportunity to develop, grow, and even jump professions. In my case, it meant I’ve been able to manage teams, become a project manager, and later assume the leadership role as quality and regulatory manager.
2. You started in computer science and software development and then moved into quality and regulatory. What motivated that transition?
Well, I was asked to take the position. The business unit I worked for had difficulty replacing its retired Q&R manager. I had not even realized the position was open, nor would I have applied had I known, to be honest. However, my R&D manager thought it would be a good fit for me, and it had the advantage that the position would be filled by someone who already knew the organization and the products. I agreed to help for 3 years and then move back to R&D. Once I stepped into the role, there was always a next challenge to conquer, so I stayed busy.
3. What attracted you to the medical device sector, particularly the SaMD space?
For me, the healthcare sector is what attracted me. The relevance is clear. When I applied at Philips, the domestic appliances sector was also discussed, but making software for televisions did not really inspire me. The organization within Philips that hired me was working in SaMD. If the odds had been different, it could also have been embedded software as well.
4. You’ve built and certified Quality Management Systems from the ground up. In your experience, what are the key success factors for getting it right?
Well, that is not entirely true. When I became Q&R manager, there was already a certified QMS in place. However, I did manage several different QMS projects, triggered by organizational changes (like acquisitions, mergers, etc.). To answer your question: the key factors are having a plan, the right resources, and buy-in from management to see the plan through. For the QMS to be adopted by the organisation, you should ensure that it supports the daily work of people, translates regulations and standards into language they can easily follow, and makes sense to them. It has helped me tremendously that I did the work myself as a project manager and software engineer.
5. Looking back on your career, is there a project or challenge you’re particularly proud of? What did it teach you?
Moving from R&D into a leadership position as Q&R manager was a big jump. I had no training within Q&R at all. On top of that, it took place under difficult circumstances. It was difficult, but I came out well in the end. I’m proud of the journey that has taken me where I am today. Being so far out of your comfort zone provides a wealth of opportunity to grow but can also be draining. Holding the right balance is difficult in those situations. I believe I’ve become better at it.
6. What drew you to MedQAIR, and how do you see your role contributing to its growth and mission?
MedQAIR is in many ways the opposite of where I came from. Small, transparent, not fully established yet, short lines, agile. It is nice to be in an entirely different company. One where I feel I can have more impact again. The people and culture are important to me. Talking to Ivo and Leon felt good from the get-go. My role? I want MedQAIR to be a success. I want to help build it. My background and expertise are a good fit I believe. Partially complementary and partially overlapping. I’m sure I can learn a lot by being part of the team, and I hope to provide the same to them.
7. As someone who thrives in cross-functional environments, what’s your approach to collaboration, especially when it comes to regulatory and technical teams working together?
Building bridges is key. Talk to people. Understand their concerns, their needs, their world. Get on the same page regarding the goals to achieve and how to get there. Take time to find interpretations of the regulations and standards that fit their world and explain it to the users of the QMS. When a team understands the why, what and how, I’ve found many of them will embrace and become a collaborative team member.
8. What do you see as the most pressing regulatory challenges for SaMD manufacturers today?
The speed at which regulations and related standards change or are being developed is slow compared to how quickly technology develops. This means manufacturers miss guidance on how to meet regulations and/or miss regulations that fit their needs, making it hard to comply. On the other hand, the amount of new and additional regulatory requirements is very high. Manufacturers that are on the market in many countries require a high investment just to keep on top of all the changes.
9. How do you view the role of tools like MDIS in simplifying quality and regulatory workflows across economic operators?
To be and remain in compliance requires, amongst other things, structure and organization. MDIS helps by providing exactly that: structure, organization, and efficiency, enabling different parties to work together more effectively.
10. What areas of professional development or innovation in the MedTech space are you currently most interested in exploring?
Multiple; of course, further investment in knowledge areas that are a big deal, like AI, Privacy and Security, but also in being a consultant. That role is different from being a long-term employee at a company, so I need to explore those differences.
Closing Thoughts
Trudy’s story is a reminder that the most valuable regulatory leaders often come from diverse paths, combining technical expertise with the ability to make complex regulations practical and actionable. At MedQAIR, her experience in bridging R&D, quality, and regulatory perspectives strengthens our mission: to make compliance simpler, more collaborative, and more impactful for medical device manufacturers.
We’re excited to have Trudy on the team and look forward to the expertise and perspective she brings to supporting our clients, from guiding SaMD innovators to helping economic operators streamline compliance with tools like MDIS.
If you’re looking for expert guidance on MDR, IVDR, or SaMD compliance, book a call with MedQAIR to discuss how we can help.
