References

Office of information and regulatory affairs, “Harmonizing and modernizing regulation of medical device quality systems”: https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202004&RIN=0910-AH99

FDA, “Transition to ISO 13485:2016”: https://www.fda.gov/media/123488/download

FDA, Quality System Regulation, Code of Federal Regulations Title 21, Part 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820

References

European Medicines Agency, “First Covid-19 treatment recommended for EU authorization: https://www.ema.europa.eu/en/news/first-covid-19-treatment-recommended-eu-authorisation

9 June 2020 

References

European Medicines Agency, “EMA receives application for conditional authorisation of first COVID-19 treatment in the EU”:  https://www.ema.europa.eu/en/news/ema-receives-application-conditional-authorisation-first-covid-19-treatment-eu
US Food and Drug Administration, “FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment”:  https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-potential-covid-19-treatment