9/22/2023 0 Comments Iso 13485 standard![]() That includes your contract manufacturer for your PCBAs. Not only must your organization be certified to this quality management standard for the medical devices industry, but it is important to ensure your entire supply chain is also following these stringent requirements. One of the most important standards, however, is ISO 13485. When you’re in the medical device industry, certifications are critical, as there are several standards and regulations you must adhere to when marketing products in this space. Certifications provide consumers with the assurance that the product or services that they are using will perform or give them the results that they expect. Whether you are in an elevator or at the doctor’s office, one of the first things that you will probably notice is a certification of some sort hanging on the wall.
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