Search results
Results From The WOW.Com Content Network
Endorse this file for transfer by adding |human=<your username> to this Template. If this file is freely licensed, but otherwise unsuitable for Commons (e.g. out of Commons' scope , still copyrighted in the US), then replace this Template with {{ Do not move to Commons |reason=<Why it can't be moved>}}
Examples of data that would lead to a query: a male patient being on female birth control medication or having had an abortion, or a 15-year-old participant having had hip replacement surgery. Each query has to be resolved by the individual attention of a member of each local research team, as well as an individual in the study administration.
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Original file (1,275 × 1,650 pixels, file size: 341 KB, MIME type: application/pdf, 6 pages) This is a file from the Wikimedia Commons . Information from its description page there is shown below.
A range of software vendors offer these systems at an enterprise level (i.e. targeted at managing all documents and records within an enterprise). [1] These vendors have historically provided electronic document management systems and have acquired smaller records management system companies. The seamlessness of the integration and the original ...
Chlorine trifluoride is an interhalogen compound with the formula ClF 3.It is a colorless, poisonous, corrosive, and extremely reactive gas that condenses to a pale-greenish yellow liquid, the form in which it is most often sold (pressurized at room temperature).
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
Certification is achieved by proving the functional safety capability (FSC) of the organization, usually by assessment of its functional safety management (FSM) program, and the assessment of the design and life-cycle activities of the product to be certified, which is conducted based on specifications, design documents, test specifications and ...