MedQAIR’s Journey: Founding Story, Mission, and What Sets Us Apart (Q&A)
Regulatory compliance in the medical device industry is ever-evolving, especially with the rise of AI/ML-enabled medical devices. Navigating the regulatory landscape requires expertise, hands-on experience, and a forward-thinking approach.
Following our conversation with co-founders Leon Doorn and Ivo Flipse, we now turn to Willibrord Driessen, Chief Advisor for MedQAIR. A seasoned strategic advisor and visionary, Willibrord brings over 30 years of senior leadership experience in global medical device compliance.
He has been instrumental in shaping MedQAIR’s vision, leveraging his expertise to support startup medical device companies with business development, strategy, and planning. Here’s how his experience drives MedQAIR’s mission.
1. What inspired you to be a part of MedQAIR?
My inspiration to work at MedQAIR as an executive advisor is as follows:
As founder & CEO of Qserve group, a global MedTech consultancy group for more than 20+ years, I have experienced that there were no regulations in Europe at all. When in 1993 the MDD/IVD Directives were introduced, most Medical Device companies were unaware of the implications.
About 24 years later, in 2017, the MDR and IVDR regulations were enforced. Although there was a long trajectory of awareness for the stakeholders, the sector was not really prepared.
After leaving Qserve in 2017, I started MDRcare advisory with a clear focus based on the lessons learned from supporting medical device start-ups. I experienced again that most medical device sectors were not ready to implement the new MDR and IVDR regulations and certainly not ready for the extended post-market requirements for their medical devices.
The medical device regulatory landscape has been significantly changed, becoming more stringent in respect to compliance with requirements in the pre-market as well as the post-market phase.
With this knowledge, I noticed that the MedTech sector was confronted with more advanced medical device registration at local authorities’ databases (for example, EUDAMED), and there was a strong need for a dedicated software platform in the post-market phase. This platform should be easy to use, transparent, and fully in compliance with the applicable requirements for the Economic Operators.
So, I am happy and proud to see that the board of MedQAIR confirmed that my vision is based on my seasoned compliance experience in founding MedQAIR, which has two divisions: 1) QA/RA compliance and 2) the recently released Medical Data Information System (MDIS).
Both divisions interact with each other, which benefits manufacturers in obtaining regulatory clearance and staying in compliance in the Postmarked phase.
2. Why MedQAIR? There are other firms in this space. What specific need or gap in the market did you identify that motivated you to start MedQAIR? What makes your approach different?
MedQAIR is unique in the regulatory space, mainly their present seasoned experience (more than 150+ years) and the way the consultancy part interacts with the regulatory MDIS platform. Moreover, MedQAIR has extended software and AI expertise onboard. Knowing that, almost no medical device has AI components nowadays, creating a new field of compliance and knowledge.
3. What are the core values that underpin MedQAIR? How do these values shape the way you work with clients and approach challenges?
I want to underline that the core values of MedQAIR align with my motivation to support the company as an Executive Advisor. I see a strong approach to supporting clients with knowledge and experience, bringing their medical devices safely to patients and users in compliance with the market, and ensuring this with MedQAIR’s unique platform.
4. Starting a company is never easy. What was the biggest challenge you faced in the early days of MedQAIR, and what did you learn from it?
Having been a senior entrepreneur in MedTech for years, I know the pitfalls and challenges of starting a company. The biggest challenge is that MedQAIR has no time to start organic growth. We want to grow fast without losing quality. I see this as my biggest challenge to support the management with the right approaches and decisions.
Using my huge network makes it possible for MedQAIR management to focus on global and potential clients and new staff opportunities.
5. What does success look like for MedQAIR beyond just financial metrics? What kind of impact do you hope to have on the medical device industry and patient care?
The success of MedQAIR is the dedicated management, staff, and stakeholders with the right care and knowledge to have safe products for patients & users now and in the future.
Final Thoughts
With over three decades of experience in global medical device compliance, Willibrord Driessen, understands the challenges startups face in navigating regulations while driving innovation. MedQAIR was founded to bridge the gap between compliance and the rapid advancements in AI-driven medical technology.
By combining deep industry expertise, strategic guidance, and digital solutions, MedQAIR helps manufacturers confidently navigate complex regulatory landscapes. Stay tuned for more insights from our team as we continue sharing our vision for the future of medical device compliance.
To learn more about how MedQAIR can support your regulatory needs, contact us today.
