• (0)
    ISO-13485-blog

    Tag: “ISO 13485:2016”

    Managing cleanliness of a product and contamination control according to ISO 13485:2016
    Most medical devices interact with the human body during the surgical process; just imagine if we didn’t have a cleaning...
    Most medical devices interact with the human body during the surgical process; just imagine if we didn’t have a cleaning process or sterilization process in place. Then, all of those medical devices would transfer physical...
    How to use ISO 13485:2016 to manage implantable medical devices
    A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended...
    A medical or surgical device is meant to interact with the human body during surgery, while some devices are intended to stay in a human body for an extended period of time. Devices that interact...
    How to comply with ISO 13485:2016 requirements for handling complaints
    Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and...
    Medical devices, implants, and surgical instruments are critical healthcare products in which consumers and practitioners look for high precision and accuracy. Therefore, during the production, sales, and other customer-related processes, complaints are a vital and...
    Infographic: What’s new in the 2016 revision of ISO 13485
    To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs....
    To get a better overview of the relationship between ISO 9001 and ISO 13485, see this article: ISO 9001 vs. ISO 13485.   The new 2016 revision of ISO 13485, the leading international standard for...