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Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
Mapping Intimacies
◽
10.3403/30368734u
◽
2018
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
In Vitro Diagnostic
◽
Systems Requirements
◽
The Relationship
Download Full-text
Related Documents
Cited By
References
Guidance on the relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
10.3403/30368734
◽
2018
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
In Vitro Diagnostic
◽
Systems Requirements
◽
The Relationship
Download Full-text
Medical devices. Quality management systems. Requirements for regulatory purposes
10.3403/30258513
◽
2012
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
Medical devices — Quality management systems — Requirements for regulatory purposes
10.5555/iso13485:2003
◽
2003
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
Medical devices. Quality management systems. Requirements for regulatory purposes
10.3403/30257645
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2016
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
Tracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes
10.3403/30390320
◽
2019
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
ISO 13485:2003 Medical Devices — Quality Management Systems — Requirements or Regulatory Purposes
Handbook of Medical Device Regulatory Affairs in Asia
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10.1201/b14081-17
◽
2013
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pp. 159-178
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
ISO 13485:2016: Medical Devices— Quality Management Systems— Requirements for Regulatory Purposes
10.1201/9781003207696-17
◽
2021
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pp. 169-189
Author(s):
Gert Bos
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
Tracked Changes. Medical devices. Quality management systems. Requirements for regulatory purposes
10.3403/02201760u
◽
2019
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
Medical devices. Quality management systems. Requirements for regulatory purposes
10.3403/02855595
◽
2003
◽
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
ISO 13485: medical devices - quality management systems - requirements for regulatory purposes
Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification
◽
10.1049/pbhe012e_ch5
◽
2018
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pp. 51-67
Keyword(s):
Quality Management
◽
Medical Devices
◽
Management Systems
◽
Quality Management Systems
◽
Systems Requirements
Download Full-text
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