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ISO 13485 (1st Edition). 2000: EN ISO 13485 is published by CEN, creating a European Norm version of the international standard, and the previous European standard (EN 46001) is withdrawn. 2003: ISO 13485 (2nd Edition). 2012: EN ISO 13485 is revised so that it harmonizes with the three European directives associated with the medical sector: 93 ...
ISO 13485 is a voluntary standard that contains section 7.3 Design and Development recommending which procedures should be put in place by manufacturers in order to have a quality system that will comply with MDD 93/42/EEC and the MDR.
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.
ModusLink Receives ISO 13485 Certification for Medical Device Manufacturers —Leading manufacturers of consumer-oriented medical devices certify ModusLink according to their ISO-based quality ...
BIS is a founder member of International Organization for Standardization (ISO). It represents India in the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC) and the World Standards Service Network (WSSN).
ISO 9000:2005 provides information on the fundamentals and vocabulary used in quality management systems. ISO 9004:2009 provides guidance on a quality management approach for the sustained success of an organization. Neither of these standards can be used for certification purposes as they provide guidance, not requirements.
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This uses an international standard, ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes. World Bank Group explain that private standards cannot be used in technical regulation and have to be moved into the public standardization system before they can be used as the basis for technical regulations.
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