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The EN ISO 13485:2016 is a standard for a quality management system specifically tailored to the regulatory requirements of the medical device industry. The brochure is aimed at manufacturers of medical devices as well as companies involved in the supply chain, such as suppliers, contract manufacturers, private label manufacturers, and EU representatives. Additionally, it targets individuals involved in the implementation and maintenance of a quality management system, as well as those preparing for certification according to EN ISO 13485:2016, such as quality management representatives and internal auditors. It interprets and explains the requirements of EN ISO 13485:2016. The brochure provides an introduction for first-time users and serves as a reference for specific questions. It conveys an understanding of the standard's requirements and highlights the interfaces with individual departments. Furthermore, it illustrates, through practical examples, how the requirements of the standard can be met.

Actual product image Die EN ISO 13485:2016 (German, Paperback, Canshia Teubert)

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