Medical Device Industry Assessment

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ISO 13485 Medical Devices

Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes is an International Organization for Standardization (ISO) standard, was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
  • Benefits

Our future client's should implement ISO 9001 if:

  • There is a need to assess and show that the organisation is consistently capable of providing products and services that meet customer requirements and comply with all relevant statutory and regulatory requirements.
  • There is a need to demonstrate that the organisation can enhance customer satisfaction because it is consistently capable of continually improving both its products and services and its practices and processes.

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