August 6, 2019 By Danielle Kirsh Brazil regulators require electronic submission of medical device FSCAs
July 15, 2019 By Danielle Kirsh How human factors validation investigators identify user groups and populations
July 12, 2019 By Danielle Kirsh European Commission publishes guidance on responsible person requirements under MDR, IVDR
July 11, 2019 By Danielle Kirsh China NMPA releases new eRPS medical device registration system details
July 10, 2019 By Danielle Kirsh FDA issues final rule for appealing medical device regulatory decisions
July 3, 2019 By Danielle Kirsh South Korea trade group, Emergo partnered for medical device RA/QA support