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The guidance document "MEDDEV 2.12-1 rev 8" offers a comprehensive guidance on best practice for medical device post-market surveillance (materiovigilance). The concept of post market surveillance is linked to the concepts of vigilance and market surveillance. A manufacturer of medical devices is required to report incidents (serious adverse ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
Since 2003, Johnson & Johnson and Boston Scientific have both claimed that the other had infringed on their patents covering heart stent medical devices. The litigation was settled when Boston Scientific agreed to pay $716 million to Johnson & Johnson in September 2009 and an additional $1.73 billion in February 2010. [ 174 ]
Edwin Smith Papyrus (c. 1500 BCE) - Earliest mention of the brain; the pulse; the role of the heart in circulating blood, but not complete circulation. [1] It is the world's oldest surgical textbook, [2] containing descriptions of the zygomatic bone, dura mater, cerebrospinal fluid, and nasal cavity. [2] Brugsch Papyrus (c. 1200 BCE)
The company was founded by Caltech professor Arnold O. Beckman in 1935 as National Technical Laboratories to commercialize a pH meter that he had invented.. In the 1940s, Beckman changed the name to Arnold O. Beckman, Inc. to sell oxygen analyzers, the Helipot precision potentiometer, and spectrophotometers.
The code names "Astro Boy" and "Bender" were tagged internally on some of the early pre-1.0 milestone builds and were never used as the actual code names of the 1.0 and 1.1 releases of the OS. [ 12 ] The project manager, Ryan Gibson, conceived using a confectionery -themed naming scheme for public releases, starting with Android 1.5 Cupcake.
These active detectors transmit ultrasonic sound waves that are inaudible to humans using frequencies between 15 kHz and 75 kHz. The Doppler shift principle is the underlying method of operation which detects a change in frequency due to object motion. This detection occurs when the object must cause a change in the ultrasonic frequency to the ...
With each on a scale from 1 to 10, the highest RPN is 10x10x10 = 1000. This means that this failure is not detectable by inspection, very severe and the occurrence is almost sure. If the occurrence is very sparse, this would be 1 and the RPN would decrease to 100. So, criticality analysis enables to focus on the highest risks.