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Safety of Metals and Other Materials Used in Medical …
- https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices
- This risk-based approach typically includes an assessment of the device, including the material components, the manufacturing processes, the clinical use of the device including the intended...
Medical Device Safety | FDA
- https://www.fda.gov/medical-devices/medical-device-safety
- Recent Medical Device Safety Communications. The FDA's analyses and …
Safety Evaluation of Medical Devices: US Food and …
- https://journals.sagepub.com/doi/10.1080/109158199225431
- During the last 20 years, safety evaluation of medical devices has evolved from screening assays to the “pharmaceutical model” of preclinical testing. …
ISO - ISO 10993-1:2018 - Biological evaluation of …
- https://www.iso.org/standard/68936.html
- Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process This standard is available for free in read-only format Abstract …
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