Geographic Coverage: North America,
Learning Level(s): Basic: Content is introductory in nature and requires no prior knowledge or experience to grasp concepts or related exercises.
SessionType: Featured session
Understanding how software is regulated in the United States and the European Union as a medical device will aid companies as they develop and/or purchase software and define its intended purpose. This session will discuss the changes in the regulatory framework in the US based on the 21st Century Cures Acts and in the EU based on the Medical Devices Regulations, as well as consistencies and differences between jurisdictions to ensure compliance.