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Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and placing on the market of medical devices for human use. It repealed Directive 93/42/EEC on Medical Devices (MDD) and Directive 90/385/EEC on active implantable medical devices (AIMDD).
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...
Das's modification to the long curved delivery forceps (shorter in length) with axis traction devices in place, seen from the right side (left blade in front: with respect to the mother's vaginal wall).
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
The Automotive Industry Action Group (AIAG), a non-profit association of automotive companies, has documented a recommended measurement system analysis procedure in their MSA manual. [6] This book is part of a series of inter-related manuals the AIAG controls and publishes, including: The measurement system analysis manual [7]
Montevideo units are a method of measuring uterine performance during labor. They were created in 1949 by two physicians, Roberto Caldeyro-Barcia and Hermogenes Alvarez, from Montevideo, Uruguay. They are exactly equal to 1 mmHg within 10 minutes.
A measuring instrument for lengths: a typical tape measure with both metric and imperial units and two US pennies for comparison A measuring instrument is a device to measure a physical quantity . In the physical sciences , quality assurance , and engineering , measurement is the activity of obtaining and comparing physical quantities of real ...
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices. [2]