Leon Doorn
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
Your gateway to expert-led compliance training
Elevate your regulatory expertise with expert-led training designed to simplify medical device compliance.
Empower Your Compliance Journey
Stay ahead of evolving regulations with expert-led training on emerging technologies, risk management, and industry best practices. Gain the skills to navigate complex compliance landscapes with confidence.
Artificial Intelligence (EU AI Act, FDA) Training
Learn regulatory frameworks for AI-enabled medical devices, ensuring compliance with the EU AI Act and FDA guidelines.
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SaMD (Software as a Medical Device) Training
Explore SaMD development, regulatory standards like IEC 62304, and strategies to ensure compliance in medical device software.
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ISO 13485 - Quality Management System Training
Master ISO 13485 QMS principles, regulatory tools, and strategies to ensure compliance and enhance medical device quality.
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ISO 27001 - Information Security Management System Training
Understand ISMS frameworks like ISO/IEC 27001 to protect sensitive patient data and ensure regulatory compliance in healthcare.
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MDR & IVDR Training
Navigate MDR and IVDR regulations, covering clinical evaluation, risk management, and post-market surveillance for EU compliance.
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Cybersecurity Training
Learn cybersecurity strategies to manage medical device vulnerabilities, implement effective threat modeling, and ensure regulatory compliance.
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Audit Training
Develop auditing skills for internal processes, clinical evaluations, and compliance audits to drive continuous improvement in healthcare.
ViewComprehensive, Expert-Led Training Hub
Gain industry-leading insights with structured, interactive courses designed to simplify regulations, enhance compliance, and drive industry best practices.
Meet The Team
Our Experts
Monique Greijmans
Regulatory & Quality Expert
Experienced in complex MedTech product development, driving compliance from early strategy to market launch across medical devices, IVDs, MDSW, and AI-based solutions.
Ivo Flipse
Co-Founder
An SaMD expert with 15+ years of experience specializing in MDR, and FDA compliance with a focus on cybersecurity and software lifecycle management.
Trudy Kunnen
Principal Consultant
A healthcare informatics expert with 30+ years’ experience in software, quality, and regulatory affairs across medical devices, IVDs, AI, and clinical IT.
Eva Kurilova-Sahin
Consultant
Clinical scientist with 10 years’ experience across clinical research and medical AI, with growing expertise in regulatory affairs for healthcare technology.
Maurice Veerkamp
Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory know-how with hands-on software development experience.
Lauren Perez
Jr. Quality & Regulatory Consultant
Biomedical Sciences graduate supporting quality and regulatory activities with experience in data integrity, documentation, and research processes.
Mike Graney
Business Development Executive
With 20+ years in economic development, including 10 at CRDA, Mike now leads Graney LLC, advising clients like MedQAIR. He specializes in FDI, life sciences, and transatlantic investment.
Hugo Messer
Co-Founder
An agile entrepreneur and venture builder, skilled in building IT solutions and remote teams across the globe.
Sarah Smith
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and compliance in healthcare technology.
Sanjay M
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to building robust, scalable technology solutions.
Yedu Panicker
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns, lead generation, and brand growth.
Preethi Philip
Content Lead
An experienced content specialist crafting compelling, high-quality content across formats to connect with diverse audiences.
Sandeep P
Digital Marketing Manager
A competent digital marketing professional with a flair for innovation and driving measurable growth through data-led campaigns.