The process of evaluating a new or modified medical device through structured experimentation while prioritizing patient safety by incorporating continuous oversight and risk mitigation strategies.
Used to document the planned evaluation process of a new medical device, emphasizing the safety protocols in place.
"Medical device innovation testing with safety monitoring will commence following IRB approval. This will involve a phased rollout with continuous data analysis and a dedicated safety monitoring committee."
Describes the methodology for the testing phase of a medical device development program, highlighting the focus on safety.
Common questions about using medical phrases in clinical documentation