Official websites use .gov
A .gov website belongs to an official government organization in the United States.
Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.
ISO 13485 + Risk Management (ISO 14971) Essentials
"ISO 13485 + Risk Management (ISO 14971) Essentials" provides medical device professionals with essential tools to manage product quality and safety throughout the device lifecycle. Participants explore documentation controls, risk analysis, and regulatory expectations. As medical devices become more connected, this training also emphasizes cybersecurity risks that arise from digital features and software components. Learners gain insights into incorporating cybersecurity considerations into risk management plans, ensuring that products not only meet safety and efficacy goals but are also resilient against cyber intrusions that could compromise patient safety or device function.
Course Overview
None
Learning Objectives
- Understand the requirements of ISO 13485 and ISO 14971.
- Apply risk management principles to medical device development.
- Develop and implement a quality management system compliant with ISO 13485.
- Analyze and interpret ISO 13485 and ISO 14971 standards.
- Prepare for ISO 13485 audits and certifications.
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.