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.

SaMD (Software as a Medical Device) Training

Explore SaMD development, regulatory standards like IEC 62304, and strategies to ensure compliance in medical device software.

ISO 13485 - Quality Management System Training

Master ISO 13485 QMS principles, regulatory tools, and strategies to ensure compliance and enhance medical device quality.

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.

MDR & IVDR Training

Navigate MDR and IVDR regulations, covering clinical evaluation, risk management, and post-market surveillance for EU compliance.

Cybersecurity Training

Learn cybersecurity strategies to manage medical device vulnerabilities, implement effective threat modeling, and ensure regulatory compliance.

Audit Training

Develop auditing skills for internal processes, clinical evaluations, and compliance audits to drive continuous improvement in healthcare.

Comprehensive, 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

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.

Monique Greijmans

Regulatory & Quality Expert

Experienced in complex MedTech product development, driving compliance from early concept through market launch and beyond.

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.

Jorrit Boersen

Consultant

Experienced in EU-MDR and global MedTech regulations, driving strategy and approvals across markets and therapeutic areas.

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.