TGFR Consulting LLC
Transforming Medical Device Development
The FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices has triggered an increased interest in cybersecurity for medical devices . This guidance from the FDA details the key elements for protecting the medical device. These elements form a hierarchy as Asset – anything that has value to an individual or …
Introduction Using agile software development for a medical device is quite possible, providing the process considers and adapts to some key constraints medical development imposes. These constraints include: Development needs defined set of Design Inputs. These input requirements represent an “engineering level of detail” for the system and are derived based upon the intended use, …