Tag: ISO 13485

7Feb

Quality Control in Manufacturing: Safety Standards That Protect Patients

Posted by Dorian Fitzwilliam 11 Comments

Quality control in medical device manufacturing saves lives by ensuring devices work safely. With ISO 13485:2016 now mandatory in the U.S., standards are clearer, global, and more effective than ever.

4Feb

Medical Device Quality Control: Safety Standards That Protect Patients

Posted by Dorian Fitzwilliam 0 Comments

Medical device quality control standards ensure patient safety through rigorous processes like ISO 13485:2016 and FDA regulations. These systems prevent device failures, reduce risks, and harmonize global compliance. Learn how quality checks and risk management protect lives and drive innovation.