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ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices.It serves a similar function to the Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
The National Council Licensure Examination (NCLEX) is a nationwide examination for the licensing of nurses in the United States, Canada, and Australia since 1982, 2015, and 2020, respectively. [2] [3] There are two types: the NCLEX-RN and the NCLEX-PN. After graduating from a school of nursing, one takes the NCLEX exam to receive a nursing license.
Meril Life Sciences is an Indian multinational medical device company, with headquarters in Vapi, Gujarat, India. It was founded in 2006 and is a part of the Bilakhia Group. [2] The company is engaged in the manufacturing of vascular intervention devices, orthopedic implants, endosurgery, ENT products and in-vitro diagnostics. Meril Life ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Hindustan Syringes & Medical Devices was established in 1957 [4] and is a family run business. In 1995 new machines were required for an increase in production and so private capital was needed. The latest ramping up could be achieved very quickly because no further investment was required. [1]
It is focused on development and manufacturing of cardiac pacing technology. Once an independently operating Dutch medical company, it was acquired by Medtronic in 1986. [93] Vitatron pacemakers are interrogated and programmed by Medtronic Carelink Model 2090 Programmer for Medtronic and Vitatron Devices, using a separate interface. [94]