top of page
Medical Device Regulatory Trainings
Targeted Expertise to Navigate Complex Compliance Requirements and Accelerate Market Access
We provide specialized training programs designed to equip your team
with the precise regulatory expertise needed for medical device compliance. Our tailored programs address foundational concepts and advanced regulatory topics, delivered by Shay Leventhal-Gabay & professionals who understand the practical challenges of implementing requirements.
Our Training Includes:
Regulatory Frameworks
FDA, EU MDR, and international regulatory pathways
Standards Training
ISO 13485, IEC 62304, ISO 14971, and other critical standards
Quality Management Systems
Practical QMS implementation and maintenance
Specialized Topics
FDA, EU MDR, and international regulatory pathways
Compliance Culture
Strategies for organization-wide regulatory awareness
Our approach combines technical expertise with practical application, ensuring your team can immediately apply their knowledge to real-world regulatory challenges
Events
bottom of page