November 19, 2018 By Danielle Kirsh What a draft Brexit agreement means for the medical device industry
November 6, 2018 By Danielle Kirsh ANVISA report shows increase in medical device modification submissions
November 5, 2018 By Danielle Kirsh South Korean medical device regulators to align quality requirements with ISO 13485:2016
October 26, 2018 By Danielle Kirsh FDA clarifies human subject requirements for clinical investigations
October 25, 2018 By Danielle Kirsh KPMG and RAPS finds many medical device companies underprepared for European MDR
October 24, 2018 By Danielle Kirsh Chinese regulators add more medical devices, IVDs to clinical trial exemption list
October 23, 2018 By Danielle Kirsh Changes to ISO 14155 standard for medical device clinical investigations expected in 2019
September 14, 2018 By Danielle Kirsh Brazil ANVISA develops new regulations for custom-made medical devices