Introduction to 13485 - How to build and maintain an effective quality system
May 02, 2011
Helsinki, Finland
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.
Key topics
- The directives - General overview on how this standard is positioned in the regulatory landscape. Other relevant harmonized standards
- Global - GHTF and similar initiatives
- Quality system implementation - Issues to consider and be aware of when implementing a quality system
- Scope and definitions
- Management responsibilities
- Resources
- Product development
- Measurements, analysis, improvements
- Comparison to ISO 9001 - Similarities and differences
- Comparison to QSR - Similarities and differences
Date and Location
This is a two day course that will take place in Helsinki, Finland on May 2-3, 2011.
Registration
This course is a cooperation with the Finnish Healthcare Technology Association (FiHTA), if you are interested in participating, please contact Terhi Kajaste, Managing Director at FiHTA, on telephone +358-50-5765536 or email terhi.kajaste@techind.fi.