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Squadhouse Media GmbH & Co. KGEN ISO 13485 web documentation

EN 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.

The SQ QM web documentation therefore documents:

  • Who has what content on the website and when
  • created , checked , approved and changed.

Please note: We offer this product exclusively for WordPress websites. Please do not hesitate to contact us.

 

_Features

  • Excellent for recording changes within the framework of DIN EN ISO 13485 / MDR
  • Complete recording of all changes within a WordPress website
  • Recording of changes that are generated by plugins
  • Partial restoration of changes
  • Documentation by date, user, time, area
  • Filter by date and area
  • Notification by email and SMS
  • Regular change reports
  • Export option via HTML and CSV (Excel)

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