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QMS for Medical Devices

ISO 13485 is an International Standard specifies regulatory requirements for a quality management system that can be used by any organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final commissioning & decommissioning, and disposal of medical devices. This is a development of the world most successful quality management standard (Requirements for regulatory purposes) specific to the organizations providing medical devices. ISO 13485 includes both ISO 9001 requirements and new medical devices and related services requirements. This standard is a specification for building and operating a medical device related, quality management system, including measuring and maintaining the systems effectiveness

Few Benefits

  • Ability to meet regulatory requirements
  • Enhance the organization’s capability to address product safety and effectiveness
  • Organizations to obtain external recognition of conformity
  • Motivate staff and provide a better definition of roles and key responsibilities
  • Adds transparency to the way complaints, surveillance or product recalls
  • Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints
  • Reduce operational costs by highlighting process deficiencies and improving efficiency
  • Improve market Credibility
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