Understanding and Implementing the Medical Device Directive 2014

Key Topics

• Integrate the Clinical Evaluation in the MDD into the essential requirements and risk management processes
• The MDD Essential Requirements and document compliance
• Prepare for Unannounced Inspections
• The conformity assessment paths and how they apply to particular devices
• The role of the harmonized standards in demonstrating the Essential Requirements
• The role of EN ISO 13485:2012 and its relationship to conformity assessment
• The medical device classification system and how to apply it
• The requirements for Risk Management and the use of EN ISO 14971:2012
• The role of product directives in the EU
• The vigilance system including reporting, Field Safety Corrective Action, and Field Safety Notice

Who should Attend

• Clinical Managers
• Regulatory Managers
• Quality Managers and Directors
• Export Compliance Managers
• Marketing Managers