Medreg offers specialized training programs designed to enhance regulatory knowledge and practical understanding of medical device compliance requirements. Our training covers key regulatory frameworks, submission pathways, quality management requirements, and technical documentation applicable to medical devices, with a focus on FDA regulations and other relevant international requirements.

FDA Medical Device Classification
Premarket Notifications (510(k)) Submissions
FDA Establishment Registration and Device Listing
UDI and GUDID Registration
QMSR and ISO 13485 Compliance
Design Control Documentation
Medical Device Labelling
Biocompatibility and Biological Safety Evaluation
Risk Management and Technical Documentation
Regulatory Reporting and Medical Device Reporting (MDR)
FDA Q-Submission / Pre - submission
Device Master Record (DMR) and Device History Record (DHR)
FDA Inspection Readiness
Import, Export
U.S. Agent Requirements

The programs are intended to help medical device manufacturers, regulatory affairs professionals, quality assurance teams, and other industry personnel understand applicable regulatory obligations and develop the skills needed to implement effective compliance practices.

Our training sessions address both the fundamental principles and practical aspects of regulatory compliance, helping participants understand device classification, regulatory pathway selection, premarket submission preparation, quality system implementation, labelling requirements, and biological safety evaluation.