Quality Management Demystified

You designed an innovative medical device that will improve health and save lives. Now you’re beginning the process of getting your medical device ready for approval. The process seems daunting but not impossible to understand. So let’s break it down with some basic facts about the quality management system and a little science.

What is a Quality Management System?

A quality management system (QMS)  consists of a set of processes strictly governed by a framework of policies and procedures used during the development and manufacturing of products. The Good Manufacturing Practice specified by FDA 21 CFR Part 820 and ISO 13485 regulates QMS. Namely, the scientific method, like the laws of science, govern a quality system.

Why Do You Need A Quality System?

Firstly, the quality system makes sure you adhere to standards set by the government with testing, documentation, and scientifically valid records. Secondly, QMS ensures the scientific validity of your product to treat, cure, diagnosis, etc and do no harm to individuals. Finally, a quality system ensures you are able to get the clearance or approval you need with regulatory agencies, that you remain in good standing, and keep your product on the market safely.

Before You Submit

In fact, even before you submit your application for your medical device, you need to be confident you have a quality system already in place that produces records of the device. During the manufacturing process the FDA expects a fully functioning and compliant quality system waiting on them.

Your Design History File

More specifically, procedures, work instructions, records, and the design history file (DHF) defines the quality system. In brief the DHF is the compilation of all design, testing and manufacturing information related to the final product. Moreover, it’s the data and science behind your device. As such, a regulatory agency such as the FDA can audit the DHF and the associated facilities that helped design, develop and manufacture the device to ensure that the product is safe and effective for use. They also audit to ensure that the device adheres to its performance claims and regulatory requirements.


In short, a quality management system ensures the FDA clears or approves your device continues to remain safe for use. As such, agencies, such as the FDA, require a QMS for your device throughout its product life cycle. Therefore, MAE Group offers a full suite of services for your product including all phases of the design, development, and implementation of a quality management system for your unique medical device. Read more.

What is a quality management system?

A quality management system (QMS) is a set of processes strictly governed by a framework of policies and procedures for the development and manufacturing of products.

What is the purpose of a quality management system?

A QMS ensures your product has been scientifically proven to treat, cure, diagnose, and do no harm. A quality system ensures a medical device gets the approval or clearance needed with regulatory agencies, keep the product on the market, and remain in good standing.

Who requires a quality management system?

Agencies such the FDA require a QMS for a device throughout the product life cycle.

How is a quality system defined?

A quality system is defined through procedures, work instructions, records, and the design history file.

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