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Medical devices were exempt in the original directive. [24] RoHS 2 narrowed the exemption's scope to active implantable medical devices only (Category 4h). In vitro diagnostic devices (IVDD) and other medical devices are now included. [25] Automotive vehicles are exempt (Category 4f).
In scientific research, the null hypothesis (often denoted H 0) [1] is the claim that the effect being studied does not exist. [note 1] The null hypothesis can also be described as the hypothesis in which no relationship exists between two sets of data or variables being analyzed.
CE marking example on a mobile phone charger. The presence of the logo (from French, "conformité européenne" meaning "European conformity") [2] on commercial products indicates that the manufacturer or importer affirms the goods' conformity with European health, safety, and environmental protection standards.
It is valuable to failure test or stress test a complete consumer product. In mechanical terms this is the operation of a product until it fails, often under stresses such as increasing vibration, temperature, and humidity. This may expose many unanticipated weaknesses in the product, and the data is used to drive engineering and manufacturing ...
The plan should document data priority and failure analysis, testing activities, and change control procedures. Internal audits play a key role in HIPAA compliance by reviewing operations with the goal of identifying potential security violations. Policies and procedures should specifically document the scope, frequency, and procedures of audits.
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. [1] REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.
The medical record serves as the central repository for planning patient care and documenting communication among patient and health care provider and professionals contributing to the patient's care. An increasing purpose of the medical record is to ensure documentation of compliance with institutional, professional or governmental regulation.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
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