All Medical Device Regulations articles
-
News BriefBecton Dickinson pays $175M for misleading investors about flawed IV pump system
Becton Dickinson medical device company will pay $175 million for “repeatedly” misleading investors about its Alaris infusion pump, a product the company knew was flawed and was sold without the required patient-safety approvals, the Securities and Exchange Commission said.
-
Blog
FDA, DHS partner on medical device cyber-security
The Food and Drug Administration and Department of Homeland Security have announced a new framework for greater coordination and cooperation when addressing cyber-security in medical devices.
-
Article
New EU medical device regulations pose many compliance challenges
Companies that market or sell medical devices within the EU will have to abide by significant new rules regarding product classification, clinical evaluations, quality management, and more.