ISO 13485 is a medical device and equipment quality management system standard. The standard mandates that an organization applies in one or more phases of a medical device's life cycle in order to meet the Medical Device Regulatory Compliances. ISO 13485 stipulates that medical devices must be free of pollutants, disinfected, and kept clean during their entire life cycle. ISO 13485:2016 is the latest version of this standard, updated frequently to ensure continuous quality improvement. We Provide ISO 13485 Certification for Medical devices.
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