Regulated environments and overarching themes

information security


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medical technology

  • Computer Software Validations (CSV) that you need to distinguish and perform

      Computer software used for the quality management system (e.g. document management, tickets) ISO13486:2016 chapter 4.1Software validation for software used in production or service provision (ISO 13485:2016, chapter 7.5.6)Software validation for computer software used for monitoring and measuring requirements (quality control) (ISO 13485:2016, chapter 7.6)Computer Software Validation, for software in the medical device, or Software as a Medical Device (SaMD) - See also Medical device Software - Software Lifecycle processes , IEC 62304:2006 & A1:2015)
  • Work in progress - still empty

    Work in progress - still empty

  • Work in progress - still empty

    Work in progress - still empty

ISO 27001 implementation

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Add a description of the tab with relevant information for website visitors. If you offer services, you should explain what distinguishes each service. If you use tabs to promote what a restaurant has to offer, describe what makes each dish special.

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description title

Add a description of the tab with relevant information for website visitors. If you offer services, you should explain what distinguishes each service. If you use tabs to promote what a restaurant has to offer, describe what makes each dish special.

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Case studies - examples