Beitrittsdatum: 25. März 2022

ISO 13485 is a quality management system standard for medical devices and instruments. The standard requires an organization to adopt during one or more stages of a medical device's life cycle to meet Medical Device Regulatory Compliances. ISO 13485 specifies that medical devices must be free of contaminants, disinfected and kept clean throughout their entire life cycle. ISO 13485:2016 is the latest version of this standard, which is updated regularly to ensure quality is continuously improved. ISO 13485 provides businesses with guidance on how to effectively implement a quality management system in medical device manufacturing or medical service related organizations. The ISO 13485 standard ensures that medical devices are designed, developed, manufactured, installed and delivered in a manner consistent with their intended functions.chứng nhận iso 13485

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