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    ISO-13485-blog

    All posts by: Mark Hammar

    What is EU MDR?
    What does EU MDR mean? The EU MDR is the European Union Medical Device Regulation 2017/745 that were released in...
    What does EU MDR mean? The EU MDR is the European Union Medical Device Regulation 2017/745 that were released in 2017 by the European Parliament and the Council of the European Union. The intent of...
    What is ISO 13485?
    What is the purpose of ISO 13485? ISO 13485 is the medical device industry’s most widely used international standard for...
    What is the purpose of ISO 13485? ISO 13485 is the medical device industry’s most widely used international standard for quality management. Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is...