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BS EN ISO 13485:2016+A11:2021

Medical devices. Quality management systems. Requirements for regulatory purposes

General Information

Status : Definitive
Standard Type: Main
Document No: BS EN ISO 13485:2016+A11:2021
Document Year: 2016
Pages: 90
  • Section Volume:
  • GBM04 Management, Law & Quality (GMB04)
  • ICS:
  • 03.100.70 Management systems *Standards included in this sub-group shall also be included in other groups and/or sub-groups according to their subject *Including environmental management systems (EMS), road traffic management systems, energy management systems, hea
  • 03.120.10 Quality management and quality assurance
  • 11.040.01 Medical equipment in general

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Definitive
BS EN ISO 13485:2016+A11:2021
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