Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar 2016 covers topics such as:
- 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
Understanding and Implementing the Medical Device Directive: 2-Day In-person Seminar 2016 brings together:
- Quality Managers and Directors
- Regulatory Managers
- Clinical Managers
- Marketing Managers
- Export Compliance Managers
