Quality Management is a framework by which a company documents how technology development decisions are made, assures that customer requirements are met, and identifies the testing methodologies to demonstrate that products are safe.
Commercialization Process: Quality Management
Description
How this Milestone Reduces Project Risk
Defining and following a quality management system creates a historical file of why, when, and by whom decisions were made. This system provides evidence of sound judgement and good business practices and therefore reduces commercialization risks.
What to consider at this time
Implementing a quality management system (QMS) is how businesses safeguard their assets. Quality management systems come in many varieties, from self-created to on-line templates. Requirements for QMS may be dictated by federal regulations, in the case of a medical product, or common sense and good practice.
Ready to get started?
In this module you will learn how to:
- Design a quality management system best suited to your company or product idea.
- Track and record decision making processes from product development to sales.
Module Guide
Learn what a QMS is and where it fits into your commercialization pathway in this guide.
Supplemental Reading
Are you developing a medical device? Learn more about regulations through this reading and determine an appropriate QMS for your development.
QMS Presentation
This presentation on QMS for medical products outlines the requirements that your product development process may need to follow. If you have questions or would like someone to walk through the presentation with you, reach out to TREAT staff.