Sampling for Medical Devices

Posted on August 2, 2011. Filed under: ISO, ISO 13485, medical devices, sampling plan, sampling plan for the medical devices |

Sampling is that part of statistical practice concerned with the selection of a subset of individuals from within a population to yield some knowledge about the whole population, especially for the purposes of making predictions based on statistical inference.

Researchers rarely survey the entire population for two reasons (Adèr, Mellenbergh, & Hand, 2008): the cost is too high, and the population is dynamic in that the individuals making up the population may change over time. The three main advantages of sampling are that the cost is lower, data collection is faster, and since the data set is smaller it is possible to ensure homogeneity and to improve the accuracy and quality of the data.

Each observation measures one or more properties (such as weight, location, color) of observable bodies distinguished as independent objects or individuals. In survey sampling, survey weights can be applied to the data to adjust for the sample design. Results from probability theory and statistical theory are employed to guide practice. In business and medical research, sampling is widely used for gathering information about a population.

Ok now to the main point of the statistical sampling plan for the medical devices. The ISO standard for the sampling of the same is attached for your reference.

Download for free for only personal information and educational purpose only.

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