Medical devices - quality management systems - requirements for regulatory purposes (ISO 13485:2003, IDT)

Míreanna comhchosúla

• Medical devices. Quality management systems. Requirements for regulatory purposes (ISO 13485:2016+A11:2021) /
  de réir: British Standards Institution, owner 8096
  Foilsithe / Cruthaithe: (2021)
• Medical devices - quality management systems - guidance on the application of ISO 13485:2006
  de réir: Department of Standards Malaysia
  Foilsithe / Cruthaithe: (2007)
• Biological evaluation of medical devices - part 1 : evaluation and testing (ISO 10993-1:2003, IDT)
  de réir: Department of Standards Malaysia
  Foilsithe / Cruthaithe: (2005)
• Nomenclature - specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 and its amendment 1:2004, IDT)
  de réir: Department of Standards Malaysia
  Foilsithe / Cruthaithe: (2005)
• Medical devices - application of risk management to medical devices (first revision) (ISO 14971:2007, IDT)
  de réir: Department of Standards Malaysia
  Foilsithe / Cruthaithe: (2009)