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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 ...
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 ...
The analysis of 402,051 hip replacements showed that 6.2% of metal-on-metal hip implants had failed within five years, compared to 1.7% of metal-on-plastic and 2.3% of ceramic-on-ceramic hip implants. Each 1 mm (0.039 in) increase in head size of metal-on-metal hip implants was associated with a 2% increase in failure rate. [64]
A revision of DSM-5, titled DSM-5-TR, was published in March 2022, updating diagnostic criteria and ICD-10-CM codes. [52] The diagnostic criteria for avoidant/restrictive food intake disorder were changed, [ 53 ] [ 54 ] along with adding entries for prolonged grief disorder , unspecified mood disorder and stimulant-induced mild neurocognitive ...