ISO 13485
ISO 13485 is a quality management standard for medical devices. It defines a set of quality management requirements. The purpose of this standard is to help both medical devices suppliers and service providers to meet customer expectations and requirements. ISO 13485 applies to medical device suppliers and medical device service providers of all kinds. It applies to organizations that participate in one or more stages of the product life cycle. Also that design, develop, produce, store, distribute, install, or service medical devices and to organizations that design, develop, or provide related medical device support service activities.
ISO 13485 in General
The benefits of adhering to ISO 13485, which outlines the quality management
system standards for medical devices, include efficient cycle times, less waste and a reputation
for reliability that can permeate throughout the medical industry.
Over all, the end customer will have more trust of the products manufactured and distributed by and organization
that is ISO 13485 certified.
What we can do for you in ISO 13485:2016?
-
A: ISO 13485:2016 Documentation templates or customized
-
B: ISO 13485:2016 Implementation and Consultation
-
C: Internal Audit for ISO 13485:2016
-
D: Arrange an independent audit through a reputed accredited certification body
-
E: Full package: ISO 13485:2016 final certificate with all documents, implementation plan, training and internal audit.