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

Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency.

This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants will have exercises that apply the principles and help solidify learning.

Course Objectives
- Understand the role of product directives in the EU
- Learn the medical device classification system and how to apply it
- Comprehend the conformity assessment paths and how they apply to particular devices
- Understand the Essential Requirements and how to document compliance
- Learn the role of ISO 13485 as the fundamental Quality Management System
-Understand the requirements for Risk Management and the use of ISO 14971
- Integrate the Clinical Requirements in the MDD into the essential requirements and risk management processes