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
October 15, 2019 By Medical Design and Outsourcing FDA updates telehealth and digital products guidance for medical device qualifications
September 30, 2019 By Danielle Kirsh Emergo Group launches new RAMS digital medical device RA/QA management system
September 24, 2019 By Danielle Kirsh FDA finalizes guidance on special and abbreviated 510(k) programs
September 20, 2019 By Danielle Kirsh Key questions for medical device companies to tackle gaps in cybersecurity processes
September 18, 2019 By Danielle Kirsh What cybersecurity compliance support should look like for medical device developers