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 ◽

pp. 51-67

Keyword(s):

Quality Management ◽

Medical Devices ◽

Management Systems ◽

Quality Management Systems ◽

Systems Requirements

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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

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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

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

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

10.5555/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 ◽

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 ◽

10.1201/b14081-17 ◽

2013 ◽

pp. 159-178

Keyword(s):

Quality Management ◽

Medical Devices ◽

Management Systems ◽

Quality Management Systems ◽

Systems Requirements

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ISO 13485:2016: Medical Devices— Quality Management Systems— Requirements for Regulatory Purposes

10.1201/9781003207696-17 ◽

2021 ◽

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