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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 ...
The Simple Function Point (SFP) method [1] is a lightweight Functional Measurement Method. The Simple Function Point method was designed by Roberto Meli in 2010 to be compliant with the ISO14143-1 standard and compatible with the International Function Points User Group (IFPUG) Function Point Analysis (FPA) method.
Template:MoS-guideline for MoS subpages. Template:Subcat guideline for other guidelines not necessarily part of the Wikipedia MoS. {{Manual of Style}}, the Navbox version of this template intended for use at the bottom of a page. Wikipedia:Template messages/Cleanup § Style of writing
A measurement system analysis (MSA) is a thorough assessment of a measurement process, and typically includes a specially designed experiment that seeks to identify the components of variation in that measurement process. Just as processes that produce a product may vary, the process of obtaining measurements and data may also have variation ...
A functional specification is the more technical response to a matching requirements document, e.g. the Product Requirements Document "PRD" [citation needed]. Thus it picks up the results of the requirements analysis stage. On more complex systems multiple levels of functional specifications will typically nest to each other, e.g. on the system ...
A style guide is a set of standards for the writing, formatting, and design of documents. [1] A book-length style guide is often called a style manual or a manual of style (MoS or MOS). A short style guide, typically ranging from several to several dozen pages, is often called a style sheet. The standards documented in a style guide are ...
In general, editors should choose images of the sort they find in high-quality reliable sources, with the least distraction or irrelevancies (e.g., high heels on an otherwise naked woman or visible genitals in an image that is supposed to illustrate Navel), and use appropriate captions to maximise the educational value of the images.
To establish a reference range, the Clinical and Laboratory Standards Institute (CLSI) recommends testing at least 120 patient samples. In contrast, for the verification of a reference range, it is recommended to use a total of 40 samples, 20 from healthy men and 20 from healthy women, and the results should be compared to the published reference range.