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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.
Peterson believed that medical devices and industrial controls would become dominant applications of the technology. [ 36 ] Defining the Internet of things as "simply the point in time when more 'things or objects' were connected to the Internet than people", Cisco Systems estimated that the IoT was "born" between 2008 and 2009, with the things ...
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.
Agile software development methods were initially seen as best suitable for non-critical product developments, thereby excluded from use in regulated domains such as medical devices, pharmaceutical, financial, nuclear systems, automotive, and avionics sectors, etc. However, in the last several years, there have been several initiatives for the ...
The International Baccalaureate Organization (IBO), [1] [2] more commonly known as the International Baccalaureate (IB), is a nonprofit foundation headquartered in Geneva, Switzerland, and founded in 1968.
The name "Bluetooth" was proposed in 1997 by Jim Kardach of Intel, one of the founders of the Bluetooth SIG.The name was inspired by a conversation with Sven Mattisson who related Scandinavian history through tales from Frans G. Bengtsson's The Long Ships, a historical novel about Vikings and the 10th-century Danish king Harald Bluetooth.
ICD-10 is the 10th revision of the International Classification of Diseases (ICD), a medical classification list by the World Health Organization (WHO). It contains codes for diseases, signs and symptoms, abnormal findings, complaints, social circumstances, and external causes of injury or diseases. [1]
Cardiovascular disease (CVD) is any disease involving the heart or blood vessels. [3] CVDs constitute a class of diseases that includes: coronary artery diseases (e.g. angina, heart attack), heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, arrhythmia, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease ...