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  • IVD Smartphone glucometers

    Hope you are doing safe, recently I joined an IVD startup manufacturing company, the product is Smartphone glucometers there is no predicate device in the market, now we are planning for ISO 13485, could you suggest to me what strategy should be followed for implementation & technical documentation.
    Thanks.

  • PIMS

    Please note that ISO 27701 is based on ISO 27001, adding specific requirements related to the protection of private information, so ISO 27701 would be the best approach for a PIMS.
     
    Regarding ISO 27018, you need to consider this supporting standard only if you have specific requirements regarding the protection of information in the cloud (ISO 27701, like ISO 27001, which has enough controls for overall protection of information in cloud environments).
     
    These articles will provide you a further explanation about ISO 27001, ISO 27018, and ISO 27701:  

  • Risk owner

    Regardless of the type of risk, the risk owner should be someone with interest and authority to treat the risk.
     
    Considering that, for strategic risks, the owner should be someone from top management.
     
    By aggregated risks, I'm assuming you are referring to a set of related risks. In this case, the risk owner should be a role that can have the authority to treat all risks.
     
    Regarding dynamic risks, the general rule about interest and authority applies.
     
    This article will provide you a further explanation about risk owner:  

    This material will also help you regarding Risk management:

  • Skipping certain blocks in the document templates

    Regarding code, version, date of the version, and change history, in case all documents are accessed only through Conformio, you can remove this information from the documents (conformio features can make it possible to track this information). The purpose of this information in the document is to keep document control information available for printed versions, or for electronic versions used outside conformio (e.g., a document sent to an auditor or requested by a client or supplier).
     
    Regarding reference documents, this information is useful so people can be aware of related documents that can impact, or be impacted, by the document being read.
     
    This article will provide you a further explanation about document management:  

    This material will also help you:
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