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Office of information and regulatory affairs, “Harmonizing and modernizing regulation of medical device quality systems”:

FDA, “Transition to ISO 13485:2016”:

FDA, Quality System Regulation, Code of Federal Regulations Title 21, Part 820:

27 June 2020

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European Medicines Agency, “First Covid-19 treatment recommended for EU authorization:

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9 June 2020 

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European Medicines Agency, “EMA receives application for conditional authorisation of first COVID-19 treatment in the EU”:
US Food and Drug Administration, “FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment”:

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