Medical devices - Application of risk management to medical devices (First revision) (ISO 14971:2007, IDT)
This Malaysian Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks and to monitor the effectiveness of the controls. The requirements of this standard are applicable to all stages of the life cycle of a medical device.
Published
• (none) / (none) / MS ISO 14971:2006
PDF
04/05/2020
94
NSC 18 - Medical Devices and Facilities for Healthcare
