Squadhouse Media GmbH & Co. KGEN ISO 13485 web documentation
Record changes on the website (can be used for EN ISO 13485)
The DIN EN ISO 13485 is a quality management system for maintaining conformity in the manufacture and marketing of medical devices. The requirement of EN ISO 13485: 2016, Chapter 4.2. "Control of documents" represents a particular challenge for companies that are active in medical technology.
This chapter also includes - especially in the future - the "control of website content". From the EU regulation 2017/745 (MDR), which will come into force on May 26th, 2021, it emerges that product information must also be "managed".
In the field of medical technology, product information is understood to mean: instructions for use, certificates, clinical data, marketing materials and application descriptions that are based on the technical documentation.
Presentation of products and inventory check
Online product catalogs are the contemporary alternatives to, for example, flip catalogs or rigid PDF documents, with which many companies still present...
Record changes on the website (can be used for EN ISO 13485)
The DIN EN ISO 13485 is a quality management system for maintaining conformity in the manufacture and marketing of medical devices. The...
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