The new revision of DIN EN ISO 13485:2016 pursues a risk based approach, contains an extended scope as well as new requirements for development. During this seminar you get familiar to the new requirements of DIN EN ISO 13485, to evaluate the need of action for your organisation. Consequently you will be enabled to do a well-founded planning of necessary adaptation of your quality management system. You get a comprehensive knowledge of changes and learn through group work and practical examples how to implement the new requirements.
Content and structure of the new revision
- Important changes
- Outsourced processes
- Design and development requirements
- Risk Management
- Schedule for Certification
- Examples for Implementation