Medical Device Change Control Process

Globalization of the market has greatly enhanced competition and pressure on manufacturers to develop new and high-quality products faster at a low cost. To stay competitive, manufacturers should be fast to fulfill customer demands and quicker in adapting to changing market conditions.

Medical device manufacturing companies should establish and maintain a quality management system (QMS) to ensure safety and effectiveness for the users or consumers. The purpose of change control process is to prevent inappropriate modifications.

A change can be temporary, permanent, emergency or serious enough to close down production, where uncontrolled changes could affect the safety of products which has direct impact on public health.

Change control procedures apply to entire life cycle of product development. Changes that may occur in production equipment, materials and components, facilities, design, manufacturing processes, packaging/labeling and all documentation (SOPs, quality manual, etc.).

It can be broadly categorize into:

Documents should include in the change control process:

In the medical device industry, each modified product should be properly checked and validated by the respective department. And the change control committee reviews the test results and other information.

Manufacturers’ primary responsibility is to recognize if a proposed change could affect the safety or effectiveness of a product, effective change control process and continuous quality improvement which can ultimately help them increase customer satisfaction and prevent product recalls or regulatory violations.