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    ISO-13485-blog

    Tag: “clinical evaluation report”

    How to write clinical evaluation reports under the EU MDR
    No matter what medical device you make, if you wish to sell within the European Economic Area, you will need...
    No matter what medical device you make, if you wish to sell within the European Economic Area, you will need to meet the requirements of the Medical Device Regulation (MDR), and in particular the requirements...