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
December 21, 2018 By Danielle Kirsh Regulators focus on building processes to ensure medical device safety and security
November 28, 2018 By Danielle Kirsh Australian TGA sets new regulations for permanently implantable medical devices