July 15, 2019 By Danielle Kirsh Leave a Comment How human factors validation investigators identify user groups and populations
July 12, 2019 By Danielle Kirsh Leave a Comment European Commission publishes guidance on responsible person requirements under MDR, IVDR
July 11, 2019 By Danielle Kirsh Leave a Comment China NMPA releases new eRPS medical device registration system details
July 10, 2019 By Danielle Kirsh Leave a Comment FDA issues final rule for appealing medical device regulatory decisions
July 9, 2019 By Danielle Kirsh Leave a Comment Australia regulators publish guidance on recognized QMS standards
July 5, 2019 By Nancy Crotti Leave a Comment Senators question proposed medical device approval changes at FDA
July 5, 2019 By Danielle Kirsh Leave a Comment South Korean regulators establish new regulations for IVD devices
July 3, 2019 By Danielle Kirsh Leave a Comment South Korea trade group, Emergo partnered for medical device RA/QA support
July 1, 2019 By Danielle Kirsh Leave a Comment Critical Innovations receives breakthrough device designation for FOAM device
July 1, 2019 By Danielle Kirsh Leave a Comment European Commission warns on supply disruptions due to MDR, IVDR
June 27, 2019 By Nancy Crotti Leave a Comment 4 ways medical device manufacturers can reduce product liability risks
