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ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

This standard is fully managed by Zertic. From setting the right scoping in the quote to managing deadlines for each audit, nc and certificates. Your audit plan is automatically generated containing all information based on quote, planning, previous audit and provided documents. All relevant reports types are generated just by a push of a button in your format.

Project Details

Categories:

You will get the following right from the start:

  • Quoting and price calculation
  • Timely planning audits
  • Automatic generation of questionnaire
  • Standard reports
  • Client portal for all audit information
  • Client portal for following up NC’s
  • Automatic generation of Certificate
  • Multi-lengual standard
  • Review flow
  • Managed competencies

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