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  • Inlininig procedure for CAPA

    What action we need to do to inline our procedure for CAPA for below requirement & how to be covered in CAPA report
    "planning and documenting action needed and implementing such action, including, as appropriate, updating documentation"

  • Software as Medical Device

    We are a product development company in the Netherlands in Infrared thermography, and we would like to know how and if Software as a Medical Device and respected certification applied to our company? 

  • Implementing 13485 as a wire harness supplier

    Hi, We are supplying wire harness to automotive industries and planning to implement TS 16949. We believe there might be a requirement from our client to be 13485 certified. So I am thinking of preparing both at the same time to safe time.

    1. Does it make sense for us to implement 13485 as a wire harness supplier?

    2. If so, does it make sense to prepare both satndards at the same time?

  • Addressing Procedure pack in the ISO 13485 Manual

    How can I address the Procedure pack in the ISO 13485 Manual?

  • Difference between the Risk management parts in the Toolkits

    1. What is the difference between the Risk management parts (06) of ISO_13485_MDR_Integrated_Consultant_WL_Toolkit_Preview_EN and ISO_13485_MDR_Integrated_Documentation_Toolkit_Preview_EN?

    2. And do I nee also the risk parts (6) of ISO_13485_Documentation_Toolkit_Preview_EN?

  • Validation requirements for 13485

    What is the validation requirements for 13485, we make medical devices (injection moulding) and assembly?

  • Sterile Instruments Packaging

    I wanted to know if there is anything mentioned about Sterile packaging changing its color in ISO 13485?
    Like we make Electro Surgical instruments and some of our sterile products' packaging changed its color a little from pink not entirely.
    The packaging we used had a little issue of ink, so it didn't change its color to entirely yellow/gold as mentioned on the packaging but it did change from its original pink color.
    Can you please guide me about this issue?

  • First in Human Feasibility Study (4 to 8 patients) conducted prior to ISO 13485 Certification

    Can a First in Human Feasibility Study (4 to 8 patients) be conducted prior to ISO 13485 Certification?

  • ISO 13485 Servicing vs FDA refurbishment of medical devices

    Is there a difference between ISO 13485 definition of servicing and FDA definition of refurbishment of medical devices?

  • Requirements for Medical Gown Production under ISO 13485

    I would like to find out if there are any requirements for Medical Gown Production under ISO 13485 especially the production environment criteria. Which level of clean room should be adhered to?
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