2-day In-person Seminar: Understanding and Implementing the Medical Device Directive 2012

The 2-day In-person Seminar: Understanding and Implementing the Medical Device Directive 2012 covers topics such as:

• Medical device classification system and how to apply it
• The role of product directives in the EU
• Essential Requirements and how to document compliance
• The conformity assessment paths and how they apply to particular devices
• Requirements for Risk Management and the use of ISO 14971
• The role of ISO 13485 as the fundamental Quality Management System
• Integration of Clinical Requirements in the MDD into the essential requirements and risk management processes

Understanding and Implementing the Medical Device Directive seminar brings together attendees involved in quality or regulatory compliance for medical devices marketed in the European Union; regulatory, quality and clinical professionals working in the clinical trial, health care, medical device and biopharmaceutical sectors.