Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar 2016

Topics

• The MDD medical device classification system and how to apply it
• The role of product directives in the EU
• The MDD essential requirements and how to document compliance
• The conformity assessment paths and how they apply to particular devices
• The requirements for risk management and the use of EN ISO 14971: 2012
• The role of EN ISO 13485:2012 as the fundamental quality management system
• The clinical requirements in the MDD into the essential requirements and risk management processes

Who should Attend

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