Essentials of ISO 13485:2003 eLearning course provides a comprehensive introduction to this standard.
Learning objectives
- The purpose and concepts of ISO 13485:2003
- The requirements of ISO 13485:2003
- The rules for justified exclusions
- The process model • How ISO 14971:2007 (risk management) is related to ISO 13485:2003
- How ISO 13485:2003 relates to regulatory requirements
Prerequisite
It is recommended that students have a general knowledge of the medical device industry and medical standards.
System requirements
Minimum system requirements include:
- Any Internet-accessible computer with at least Microsoft Internet Explorer 6
- 28K or faster Internet connection
- Macromedia Flash Player 7
Note: the course will automatically detect if you have Macromedia Flash Player 7 installed. If you do not have the Flash Player, the course will allow you to download and install the software for free.
