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[2] [3] In 1966 NASA released its FMECA procedure for use on the Apollo program. [4] FMECA was subsequently used on other NASA programs including Viking , Voyager , Magellan , and Galileo . [ 5 ] Possibly because MIL–P–1629 was replaced by MIL–STD–1629 (SHIPS) in 1974, development of FMECA is sometimes incorrectly attributed to NASA. [ 6 ]
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.
Surgery [a] is a medical specialty that uses manual and instrumental techniques to diagnose or treat pathological conditions (e.g., trauma, disease, injury, malignancy), to alter bodily functions (e.g., malabsorption created by bariatric surgery such as gastric bypass), to reconstruct or alter aesthetics and appearance (cosmetic surgery), or to remove unwanted tissues (body fat, glands, scars ...
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 ...
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 ...