At MedQAIR, we work with professionals who understand that regulatory and quality activities need to be embedded throughout the product lifecycle, from early concept decisions to market access and ongoing compliance. That is especially important for today’s manufacturers working across medical devices, IVDs, medical device software, and AI-based health technologies.
We are pleased to introduce Monique Greijmans, Principal Consultant and Business Developer at MedQAIR. Monique brings experience in complex MedTech product development, with a strong focus on guiding compliance from early regulatory strategy through to market launch across medical devices, IVDs, MDSW, and AI-based solutions. MedQAIR presents her as a specialist in exactly this intersection of product innovation, compliance, and business development strategy.
What stands out in Monique’s profile is her emphasis on building the regulatory product view at the concept stage, getting the risk classification right early, and safeguarding compliance throughout development to avoid delays and rework later in the process. Her broader background also includes process improvement, change management, coaching, and organizational transformation, which makes her perspective especially relevant for manufacturers trying to connect regulatory expectations with day-to-day product development.
In this interview, we want to explore how Monique approaches business challenges for regulatory and quality aspects in practice, how she works across different product categories, and what manufacturers can do earlier and better to build a more efficient path to compliance and market access.
1. Can you tell us a bit about your professional journey and what led you into regulatory and quality work within MedTech?
Innovation has always been important to me.
My career began at Philips Research as an engineer who pioneered LCD screens and thin-film technologies. The ambition to delve into applied sciences for healthcare led me to Organon, a pharmaceutical company with a portfolio of sterile combination products and new dosage forms for which no global regulations existed at the time. That was the moment when, as a product engineer, I was drawn into the fascinating world of regulation and the importance of understanding the risk characteristics of the products you develop and produce. I learned about the opportunities and responsibilities of a manufacturer.
After 20 years in the pharmaceutical industry, I decided to switch to healthcare informatics at Philips. For me, this was a new and innovative field with a completely different approach to design management and gathering objective evidence. Here is where I helped the software development processes for medical devices transform into leaner, more agile working methods. Then, I became responsible for regulatory compliance and the development of new business activities, leading the regulatory and clinical teams for areas such as digital and computational pathology, genomics, and related software and AI-based products. Subsequently, I led the transformation of the regulatory teams for MRI, X-ray, CT, and Ultrasound into new business structures to improve regulatory compliance strategies.
Establishing my own independent regulatory consultancy firm brought me back to the essence of innovation. My passion lies in helping MedTech innovators find the best route to market and thereby improve patient care. That is exactly what I continue to do as part of the MedQAIR team.
2. You have experience across medical devices, IVDs, MDSW, and AI-enabled medical devices. What do you find most interesting about working across these different product areas?
The most interesting aspect is the link between each product type and the workflow in healthcare and patient care, the specific risk characteristics, and how these relate to differences in global regulations
3. You often highlight the importance of having the right regulatory view from the start of development. Why is that early stage so important, and what tends to go wrong when teams leave regulatory thinking too late?
The so-called ‘Valley of Death’ is a situation that occurs with start-ups and even scale-ups if they fail to take regulations into account during the product concept phase. I have seen situations where essential steps were skipped, leading to the re-execution of expensive validation studies when the budget ran out. This could have been prevented, partly through a step-by-step approach to market entry, if they had invested relatively little time and money in developing a regulatory strategy at an early stage
4. Risk classification is often one of the first major regulatory decisions. In your experience, why is getting the classification right early so critical for the rest of the product journey?
Risk classification is based on the intended purpose, the intended user, the intended usage environment, and the claims the manufacturer wishes to make. This risk classification determines all subsequent steps for design management and clinical/performance evaluation. An incorrect risk classification leads to compliance issues and delays, or even a blockage, in the market launch.
5. Many MedTech teams are moving fast on innovation while trying to stay compliant. How do you help organizations balance product development speed with regulatory and quality requirements in a practical way?
It is important to comply only with relevant regulatory and quality requirements and to do so at the right time in the product development phase. This prevents redundant tasks and unnecessary burden on the MedTech teams. This can only be effectively achieved if we, as regulatory consultants, thoroughly understand the product they are developing, including its risk characteristics. It is not about ticking off checklists, although unfortunately, this is often the case in practice.
6. You have worked in complex product development environments. What are some of the recurring gaps you see between development teams and regulatory or quality teams, and how can companies close those gaps earlier?
Communication problems lead to regulatory compliance issues. Teams in companies must establish contact early, collaborate fully, and communicate openly to ensure everyone is pursuing the same goal.
In other words: trust each other!
7. For manufacturers developing software or AI-enabled medical technologies, what are the main regulatory or quality challenges that deserve more attention today?
The ongoing changes in regulations for these types of products pose a constant challenge to the market strategy. It is essential to monitor, understand, and continuously adapt to these changes in order to keep the market strategy current. Experienced experts in the field of these regulations are required to assess their impact.
8. Your background also includes process improvement, change management, and coaching. How does that experience shape the way you support clients and internal teams?
All these aspects are essential for the development of a business strategy, of which the regulatory strategy is a part. To understand the impact, one must have insight into all other business processes affected by this. This helps to gain a broader view of the enterprise and leads to the best advice. This expertise is transferred by supporting less experienced clients and employees with these topics.
9. What does good regulatory and quality leadership look like in a growing MedTech company, especially when teams are scaling, entering new markets, or preparing for submission?
Good leadership will facilitate and promote the growth of people and MedTech companies, and retain the experience gained within these companies, so that they can take the next steps independently.
10. As you join MedQAIR, what kind of work are you most looking forward to, and where do you believe you can create the most value for clients?
Within MedQAIR, I will be fulfilling two roles.
In my role as Principal Consultant, Regulatory & Quality, I will continue to directly support clients with the content and expertise they need.
Additionally, I will take on the role of business developer to help and coach the MedQAIR team. In this way, we ensure that we build an organisation capable of meeting the growing demand from clients for the right expertise regarding the complex regulations for software and AI-based products in healthcare.
The Wrap
Monique’s perspective brings a practical and well-grounded view on regulatory and quality work in MedTech. Her focus on early decision-making, clear risk understanding, and applying requirements at the right moment reflects the kind of approach that helps teams move forward without unnecessary delays.
Her experience across devices, software, and AI-based technologies also shows how closely regulatory strategy is connected to product development and business direction. Strong communication and alignment across teams remain essential to making this work in practice.
At MedQAIR, Monique will support clients directly while also contributing to the growth and development of the team. Her expertise adds further strength to MedQAIR’s work in guiding manufacturers through increasingly complex regulatory landscapes, particularly in software and AI-driven healthcare solutions.
We’re pleased to have Monique as part of the MedQAIR team and look forward to the value she brings to our clients and partners worldwide.
If you’re developing medical devices, software, or AI-enabled healthcare solutions and want regulatory and quality thinking embedded from the start, MedQAIR supports manufacturers in building compliant and efficient development pathways. Get in touch with MedQAIR to speak with our experts.
