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Active Implantable Technology for Medical Devices | BSI …
- https://www.bsigroup.com/en-US/medical-devices/Technologies/Active-Implantable-Medical-Devices/
- Active Implantable Medical Devices and their accessories are classified as Class III and therefore subject to the most rigorous regulatory controls. For further clarity and more detailed information on an AIMD, please reference the MDR (EU) 2017/745 for EU and …
Classify Your Medical Device | FDA
- https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device
- Each classification panel in the CFR begins with a list of devices classified in that panel. Each classified device has a 7-digit number associated with it, e.g., 21 CFR 880.2920 - …
Implants and Prosthetics | FDA
- https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics
- Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other implants …
Reclassification of active implantable medical devices …
- https://www.tga.gov.au/resources/resource/guidance/reclassification-active-implantable-medical-devices-aimd
- 19 December 2022. Download PDF [349.93 KB] Download Word [435.83 KB] This guidance aims to assist sponsors of active implantable medical devices (AIMD) with …
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