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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 ...
[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.
The following six peer review practice principles stem from and are grounded in the 1988 ANA Guidelines and may help to assure an evidence-based and consistent approach to peer review: 1. A peer is someone of the same rank. 2. Peer review is practice focused. 3. Feedback is timely, routine and a continuous expectation. 4.
Management of depression is the treatment of depression that may involve a number of different therapies: medications, behavior therapy, psychotherapy, and medical devices. Depression is a symptom of some physical diseases; a side effect of some drugs and medical treatments; and a symptom of some mood disorders such as major depressive disorder ...
The second step is designed to test whether medical students can apply their medical skills and knowledge to actual clinical practice during students' fourth year of medical school. The third step is done after the first year of residency. It tests whether students can apply medical knowledge to the unsupervised practice of medicine.
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 ...