Services
About Us

As a global safety science leader, UL Solutions helps companies to demonstrate safety, enhance sustainability, strengthen security, deliver quality, manage risk and achieve regulatory compliance. 

Overview
UL Solutions Consumer Information

See how we put safety science to work to help create a safer, more secure and sustainable world for you.

Learn more
Resources

Explore our business intelligence-building digital tools and databases, search for help, review our business information, or share your concerns and questions.

Overview
UL Solutions Market Access Portal

Accelerate your planning process and learn the requirements needed to take your products to market worldwide.

Visit
myUL® Client Portal

A secure, online source for increased visibility into your UL Solutions project files, product information, documents, samples and services.

Go to myUL
Certification Database — UL Product iQ®

Access UL certification data on products, components and systems, identify alternatives and view guide information with Product iQ.

Visit
Industries
View All
  • Software and Products
Switch Language
  • Training

Introduction to the Quality System Regulation

This course provides knowledge on Good Manufacturing Practices (GMPs) which are in place to help protect medical devices and medical device users as specified in the Quality System Regulation (QSR).

Request a demo
A close up of a lab worker’s hand flipping through three-ring lab binder

Description

Good Manufacturing Practices (GMPs) help protect medical devices and medical device users. This course describes the GMPs for medical devices as specified in the Quality System Regulation (QSR). Topics in this course include quality system, design control, software validation and responsibility. After completing this course, learners will be able to identify the components of a quality system, design controls and software validation.

icon of a clock

Duration

30 minutes

icon of a gear rotating

Library

Medical Device GMP, FDA Inspections and Enforcement

icon of a book

Functional area

Medical Device and GMP, Quality System Regulations and Inspections, GMP Basics

Downloads
ComplianceWire

ComplianceWire Online and Custom Content Brochure

810.34 KB
Download
ComplianceWire

ComplianceWire Life Sciences eLearning Offerings

2.73 MB
Download
Other ComplianceWire® offerings
Graphical depiction of progress in online learning courses
  • Software

ComplianceWire®

Learning and Qualification Management System
Glass medicine bottles on a factory line
  • Software

ComplianceWire® e-Learning Library for Life Sciences
Illustration showing publishing a course in ComplianceWire
  • Software

Course Create

Create and edit training courses
X

Get connected with our sales team

Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.