Package has 4 documents
ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package
ISO 13485 / IEC 62304 / ISO 14971 - Software, Quality And Risk Management Of Medical Devices
The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package provides the support to develop, implement, and maintain a medical devices quality and risk management system. It also includes the requirements for the software life cycle process for medical device software.
The ISO 13485 / IEC 62304 / ISO 14971 - Medical Devices Package consolidates the IT, quality, and risk management medical devices necessities. It includes:
- IEC 62304 Ed. 1.0 b:2006
- IEC 62304 Amd.1 Ed. 1.0 b:2015
- ISO 13485:2016
- ISO 13485:2016 - Medical devices - A practical guide
- ISO 14971:2019
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Package has 4 documents
General Information
Standard
EN ISO 13485:2016 (EN)
English language
68 pages
Standard
EN ISO 14971:2020
English language
46 pages
Standard
IEC 62304:2006 - Medical device software - Software life cycle processes
English and French language
155 pages
Standard
IEC 62304:2006/AMD1:2015 - Amendment 1 - Medical device software - Software life cycle processes
English and French language
82 pages