February 27, 2020 By Danielle Kirsh Health Canada implements electronic medical device clinical trial data submission
January 17, 2020 By Danielle Kirsh Supporting regulatory affairs departments to address clinical requirements under new MDR
January 16, 2020 By Danielle Kirsh FDA recognizes latest ISO 14971 as medical device consensus standard
December 10, 2019 By Danielle Kirsh FDA details framework for abbreviated 510(k) medical device review pathway
October 29, 2019 By Danielle Kirsh FDA recommendations for URGENT/11 medical device cybersecurity vulnerabilities mitigation
October 28, 2019 By Danielle Kirsh European MDCG posts guidance on MDR Summary of Safety and Clinical Performance
October 16, 2019 By Medical Design and Outsourcing RAPS meeting highlights medical device regulatory challenges