Introduction to 13485 - How to build and maintain an effective quality system
Feb 28, 2011
Copenhagen, Denmark
The objective of the course is to create a basic understanding for the standard ISO 13485, which is the quality framework for the Medical Device manufacturers. The course will cover regulations, standards, design control and risk management relevant for MDD/IVDD devices and the classification system for MDD/IVDD products.
Quality management, R&D management, quality engineers and process engineers working with the following will benefit from this course: Implementation of a quality system according to MDD, updating of the current quality system, e.g. manufacturers of stand-alone SW migrating from ISO 9001 to 13485 or improvement of the quality system to be competitive on the market.
This course is a cooperation between Medicoindustrien in Denmark and Synergus.
Registration details and further information about the course can be found here.