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Medical Device Material Safety Summaries | FDA

https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-material-safety-summaries

The U.S. Food and Drug Administration (FDA) partnered with ECRI (originally founded as Emergency Care Research Institute), an independent nonprofit …

Essential Principles of Safety and Performance of …

https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf

medical device and IVD medical device is safe and performs as intended, by the manufacturer. Essential principles of safety and performance provide broad, high-level, …

Essential Performance in Medical Devices IEC 60601-1

https://www.johner-institute.com/articles/johner-institute/essential-performance-in-medical-devices/

Performance characteristics refer to the ability of a functional unit to perform a required function. These could be the aforementioned clinical functions (detection of fibrillation) or …