Smedtrum Acquired ISO 13485

Smedtrum Acquired ISO 13485

As a medical device manufacturer, Smedtrum has always valued the quality of our products and system a lot. And there is no better way to examine if our quality system is designed and working well than by applying for ISO 13485.

During the process of application, we had the chance to go through all our quality-controlling segments. From research and designing, procurement, and assembling to final product testing, we are making sure that everything is recorded and retraceable. Also, a well-monitored risk management system is built throughout the whole product life cycle, to minimize any potential hazard.

Eventually, our quality management system is proven to comply with international standards for medical device manufacturing, which is ISO: 13485 2016.