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    ISO-13485-blog

    Tag: “ISO 13485”

    What are EU harmonized standards?
    If you are a manufacturer in the European Union, it can be difficult to try to align the different standards...
    If you are a manufacturer in the European Union, it can be difficult to try to align the different standards in the various countries. As it turns out, the EU has released a list of...
    ISO enabled free access to ISO 13485 and other medical device and protective clothing standards
    To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of...
    To support the initiatives dealing with the impact of COVID-19, the International Organization for Standardization (ISO) has made some of its standards supporting the biological evaluation of medical devices and protective clothing used in health...
    How can ISO 13485 help with MDR compliance?
    As a medical device manufacturer, if you are implementing an ISO 13485:2016 Quality Management System (QMS), you may wonder how...
    As a medical device manufacturer, if you are implementing an ISO 13485:2016 Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your QMS...
    How to perform ISO 13485 training
    Implementing a Quality Management System (QMS) for your medical device manufacturing company using the requirements of the ISO 13485:2016 standard...
    Implementing a Quality Management System (QMS) for your medical device manufacturing company using the requirements of the ISO 13485:2016 standard can be difficult. Along with figuring out what needs to be done within your organization...
    How to choose a consultant for ISO 13485 implementation
    If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist...
    If your company has decided to implement the ISO 13485 standard, you might be considering bringing in a consultant to assist with the implementation process. The wise selection of an ISO 13485 consultant is one solution...
    ISO 13485 structure and requirements
    Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of...
    Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us...