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Product Systems Engineering Workshop – MedTech Edition Essentials
"Product Systems Engineering Workshop – MedTech Edition Essentials" trains engineers to deliver safe, compliant, and effective medical devices by mastering systems thinking and regulatory alignment. Participants gain insights into design controls, usability engineering, and lifecycle management. As medical devices are increasingly connected, the course includes discussions on cybersecurity risks and defense strategies to ensure patient data privacy and prevent unauthorized device manipulation.
Provider Information
Tonex, Inc.
6275 W. Plano Parkway, Suite 500
Plano, TX 75093
Course Overview
None
Learning Objectives
- Understand the principles of Product Systems Engineering (PSE) tailored for MedTech.
- Apply systems engineering methodologies to the design and development of medical devices.
- Analyze regulatory compliance and quality assurance in the MedTech sector.
- This course significantly impacts cybersecurity by ensuring that medical devices are designed with robust security controls from the outset, protecting patient data and preventing device tampering.
- Develop strategies for managing the product lifecycle in highly regulated MedTech environments.
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.