What is a quality system?

 In Medical Product Design

Makers of medical devices must balance their pursuit of technology development and user needs with a strong focus on safety and regulatory compliance. Constant attention to the guidelines set by the U.S. Food and Drug Administration is essential to gaining approval or clearance and bringing a product successfully to market. For newer businesses, setting up a strong quality system is an important step toward creating high-quality devices and staying in line with FDA requirements.

Carefully thought-out quality systems are key to building products that meet all relevant federal standards and specifications. Any business involved in the medical device product development process should have a strong understanding of what goes into setting up and following a quality system.

The parts of a quality system

“A quality system keeps an organization making products with safety and effectiveness in mind.”

A quality system consists of the business policies, practices and resources that keep an organization making products with safety and effectiveness in mind. The FDA has developed current good manufacturing practices for a variety of products regulated by the agency, including food, drugs and biologics. For medical devices, these requirements serve to maintain the well-being of patients, putting practices in place to ensure that products will function in accordance with their approved labeling.

The FDA breaks a quality system down into several interdependent subsystems that each contribute to the desired outcomes:


  • Management Responsibility.

  • Quality Audit and Personnel.

  • Corrective and Preventive Action.

  • Complaint Handling.

  • Production and Process Controls.

  • Process Validation.

  • Equipment and Facility Controls.

  • Document, Records and Change Controls.

Management must marshal all these operational aspects with the shared mission of maintaining high standards for every device. Given the variety of medical products, each with their own clinical applications and level of risk,  the FDA’s rules do allow a great deal of flexibility. A quality system should be designed according to the specific device’s complexity and the level of risk involved in using it, as well as the processes required for manufacturing and the size of the maker’s business.

Establishing the right system

Implementing a reliable quality system can be challenging, but it’s vital to meeting the demands of regulatory compliance and building a successful enterprise. In many cases, an organization benefits from seeking a partner with experience in medical device quality assurance.

At the heart of the quality system is a clearly stated policy and customized set of objectives for a manufacturer’s medical devices. Management is responsible for an organizational structure that accounts for all the technical, administrative and personnel factors that go into making the system work. At every stage of operations, the organization needs to provide all the necessary resources to fulfill the stated goals for safety and efficacy.

A regular audit process provides an important check on quality, as does extensive training of all personnel involved in designing, manufacturing and testing devices. In case any issues do arise, the corrective and preventive action subsystem must be ready to investigate and take action. By keeping quality a top priority at all times for individuals throughout an organization, a medical devices manufacturer brings about a robust product development process.


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