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ISO - ISO 14971:2007 - Medical devices — Application of …
- https://www.iso.org/standard/38193.html
- ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to …
A History of Medical Device Regulation and Oversight in …
- https://www.fda.gov/medical-devices/overview-device-regulation/history-medical-device-regulation-oversight-united-states
- 2007: Food and Drug Administration Amendments Act (FDAAA) Reauthorized the medical device user fee (MDUFA II), including improvements to premarket review times Required …
2007 Medical News, Trends, and Breakthroughs
- https://www.prevention.com/life/a20463995/2007-medical-news-trends-and-breakthroughs/
- Results published in the August 2007 Archives of Neurology show that the vaccine limits production of activated immune cells called T cells, which cause the …
ISO - IEC 62366:2007 - Medical devices — Application …
- https://www.iso.org/standard/38594.html
- It can be used to identify but does not assess or mitigate risks associated with abnormal use. If the usability engineering process detailed in this International Standard has been …
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