March 13, 2019 By Danielle Kirsh U.S., Canadian regulators warn potential medical device shortages after Sterigenics shutdown
March 12, 2019 By Danielle Kirsh Brazil ANVISA launches notification pathway for low-risk medical devices and IVDs
March 2, 2019 By Danielle Kirsh Safeguarding against no-shows and late participation in medical device usability testing
March 1, 2019 By Danielle Kirsh Brazil to implement ANVISA Class I medical device notification pathway
January 31, 2019 By Danielle Kirsh FDA final guidance on safety and performance 510(k) medical device registration
January 30, 2019 By Danielle Kirsh How diary studies can support medical device human factors engineering and usability
December 28, 2018 By Danielle Kirsh FDA finalizes guidance on Breakthrough Medical Device market pathway
December 27, 2018 By Danielle Kirsh Health Canada sets pre-market medical device cybersecurity requirements