This course provides an in-depth review of all aspects of the in vitro diagnostic regulations in Europe including their classifications, which conformity assessment routes are applicable, how to consider the essential requirements and what the post market surveillance requirements are to keep in vitro diagnostic devices safe on the European market.
Description
This course provides an in-depth review of all aspects of the in vitro diagnostic regulations in Europe including their classifications, which conformity assessment routes are applicable, how to consider the essential requirements and what the post market surveillance requirements are to keep in vitro diagnostic devices safe on the European market.
The course is based on the requirements of the current directive 98/79/EC. However, since the new draft regulation has already been published, a specific course is developed to outline the potential future requirements.
To enroll and purchase this course, please visit the WMDO website at: http://www.wmdo.org/SGS.aspx
Objectives
Upon successful completion of this course, learners will be able to
- Apply the current applicable classification rules for IVD devices in Europe
- Choose the right conformity assessment route
- Comply with the applicable essential requirements for the specific IVD devices
- Develop a post market surveillance plan for the IVD devices.
Audience
Who Should Enroll:
Regulatory associates and regulatory managers, quality assurance associates and managers, production managers, design and development engineers, regulatory body personnel.
Prerequisite Knowledge/Requirements:
An understanding of the GHTF principles for IVD devices will greatly help as pre-requisite knowledge to this course.