Quality Systems for Medical Device Manufacturing (QSMDM) Essentials from Tonex, Inc.

Quality Systems for Medical Device Manufacturing (QSMDM) Essentials

"Quality Systems for Medical Device Manufacturing (QSMDM) Essentials" focuses on building and maintaining regulatory-compliant quality systems. Participants learn industry best practices for documentation, control, and continuous improvement. In cybersecurity, quality management also extends to protecting device software, ensuring that medical devices remain secure and resistant to cyber threats that could compromise patient safety.

Course Overview

Overall Proficiency Level

2 - Intermediate

Course Catalog Number

T101

Course Prerequisites

None

Training Purpose

Functional Development

Management Development

Specific Audience

All

Delivery Method

Online, Instructor-Led

Online, Instructor-Led

Learning Objectives

Understand the requirements of Quality Systems for Medical Device Manufacturing (QSMDM).
Implement and maintain a compliant quality management system.
Learn about regulatory requirements for medical device quality.
Apply quality control and assurance principles in medical device manufacturing.
Robust quality systems in medical device manufacturing help ensure the security and integrity of the devices and their software.

Framework Connections

Oversight and Governance

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

Work Roles

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.