MDRTraining
← All modules
MDR & IVDR

International Regulatory Context

Global regulatory landscape for medical devices — FDA pathways, MDSAP, Health Canada, and strategies for multi-market access.

  1. 1

    FDA Regulatory Framework Overview

    US FDA device classification, 510(k), PMA, and De Novo pathways compared to EU MDR.

    14 minRequires: The EU Regulatory Landscape
  2. 2

    MDSAP and Multi-Market QMS Strategies

    Medical Device Single Audit Program, participating authorities, and integrated QMS design.

    14 minRequires: QMS Fundamentals under the MDR, FDA Regulatory Framework Overview
  3. 3

    Key Regulatory Differences Across Markets

    Classification, clinical evidence, and registration differences across EU, US, Canada, Japan, and Australia.

    16 minRequires: FDA Regulatory Framework Overview, MDSAP and Multi-Market QMS Strategies