ISO 13485 and Regulatory Requirements Essentials Training: Learn the essentials of ISO 13485 standards for developing and managing quality systems for medical devices.
Learning Objectives
- Learn the fundamentals of ISO 13485 requirements.
- Understand regulatory expectations for medical devices.
- Develop skills to implement a compliant QMS.
- Ensure compliance with global regulatory frameworks.
- Improve audit readiness and quality performance.
Framework Connections
The materials within this course focus on the NICE Framework Task, Knowledge, and Skill statements identified within the indicated NICE Framework component(s):
Competency Areas
Feedback
If you would like to provide feedback on this course, please e-mail the NICCS team at NICCS@mail.cisa.dhs.gov. Please keep in mind that NICCS does not own this course or accept payment for course entry. If you have questions related to the details of this course, such as cost, prerequisites, how to register, etc., please contact the course training provider directly. You can find course training provider contact information by following the link that says “Visit course page for more information...” on this page.