Medical device manufacturers often hear the term “13485 certified” thrown around, but what exactly does it mean? Being 13485 certified means that a company has met the safety and quality standards required to design, produce, and distribute medical devices.
The standard set by the International Organization for Standardization ISO is regularly reviewed and updated to ensure that manufacturers are using the latest technology and processes. It also ensures that quality is consistent across all products and that devices are safe for patient use.
Getting 13485 certified is an involved process that includes an audit of a company’s quality management system. The audit looks at documentation, procedures, and the production process to ensure that everything meets the required standards.
Why is it important to be 13485 certified? Not only does it help to ensure patient safety, but it can also improve a company’s reputation and increase its competitiveness in the market. Many regulatory agencies, such as the U.S. Food and Drug Administration, require manufacturers to be 13485 certified before they can approve a medical device for sale.
Being 13485 certified means that a medical device manufacturer has met the highest safety and quality standards required to produce medical devices. It is a rigorous process, but it ultimately ensures that devices are safe for patient use and helps manufacturers succeed in the competitive market.