Who We Are
We are a reliable medical device consulting company offering expert support in Authorised Representative services, PRRC services, and Medical Device & AI Quality and Regulatory Affairs Consulting.
About Us
MedQAIR: Your Partner in Medical Device Regulation & AI Act Compliance
A reliable and reputable medical device consulting company with a proven track record of facilitating EU market entry to medical & IVD device manufacturers. Besides ensuring
EU MDR, IVDR, and ISO 13485 compliance, we give proficient support to artificial intelligence (AI) system manufacturers to comply with the emerging AI Act.
- Professionals with decades of regulatory medical device quality and regulatory experience
- Reliable European Authorised Representative services
- Proficient PRRC Services
“As a medical device regulatory expert, my mission is to simplify entry of products into regulated markets to ensure compliance, safety, and innovation.”
Leon Doorn
FOUNDER
Mission
Simplify market entry for medical devices by guiding manufacturers through regulatory complexities.
Vision
Foster trust and reliability within the healthcare community by ensuring safety through compliance.
Value
We prioritise efficiency and transparency aiming to be the trusted partner for manufacturers in regulatory navigation.
Meet the Team
Our Experts
Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
Chief Advisor
An independent seasoned strategic advisor, a visionary with strong senior leadership experience, focusing on Medical Device compliance globally.
Co-Founder
Agile entrepreneur and venture builder, skilled in empowering distributed teams to foster innovation. Passionate about enabling investors to achieve impact + ROI.
Regulatory Expert
Experienced regulatory affairs consultant in the healthcare industry, specializing in quality systems for medical devices. Authored numerous guidelines and standards for medical technology quality and risk management.
Eline De Schutter Designatio
QA & RA Consultant
A digital health expert with over 8 years of experience in regulatory and product management, driving innovative medical software to market.
Maurice Veerkamp
QA & RA Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory knowledge & AI innovation to deliver compliant medical software solutions.
Sarah Smith
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and guiding clients through regulatory approval.
Ivo Flipse
Independent QA/RA Consultant & Security Specialist
An SaMD expert with 15+ years of experience specializing in MDR, IVDR, and FDA compliance with a focus on cybersecurity and documentation.
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to ensuring the optimal performance of our online presence.
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns and & Customer Experience Management (CX).
Content Lead
An experienced content specialist crafting compelling, high-quality content across various platforms with meticulous attention to detail.
Book a Free 30-Minute Consultation
Gain Representation & Support for Accessing the EU Markets
Accessing the EU markets through a specialized medical device consulting company is ideal and efficient. The experts in medical device regulation at MedQAIR ensure simplified entry and ongoing compliance of your medical, in-vitro diagnostics, and AI-enabled and stand-alone AI devices in European markets. As a seasoned medical device consulting company, we act as a dependable European Authorised Representative (EU AR/EC REP) and PRRC for manufacturers lacking a registered office in the EU.
