Medical devices

Health care and medical devices
ISO 13485 certification helps Beckman Coulter meet regulatory deadline for medical devices. Beckman Coulter, Inc.,implemented ISO 13485 to meet a new medical device regulation requiring registration to the standard.
Quality management systems for the medical device industry
ISO has just published a standard to facilitate implementation of quality management systems based on ISO 9001:2000 by the medical device industry.

 

Related standards

  • ISO/TR 14969:2004
    Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
  • ISO 13485:2003
    Medical devices -- Quality management systems -- Requirements for regulatory purposes

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