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Quality Audits for the Medical Device Industry Conference (Washington, DC, United States - January 25-26, 2018) - Research and MarketsThe "Quality Audits for the Medical Device Industry" conference has been added to Research and Markets' offering. Quality management systems of medical devices have to go through well-defined quality audits. Medical device companies need to implement these in order to show compliance with quality. ISO 13485 is the quality management standard for medical devices. Based on the process approach of this document and that of 21 CFR part 820 the Global Harmonization Task Force (GHTF) has set out processes for audits relating to the quality management systems of medical devices. The GHTF believes that insertion of quality management system requirements based on ISO 13485 is a first step towards global harmonization of medical devices. These guidelines are mant to lead regulators into articulating regulatory systems for medical devices. Purpose of Quality Audits according to GHTF
Definition of a Quality Audit GHTF describes the quality audit as the organizational responsibilities, processes, structure, resources and procedures taken to implement a quality management system. What should the quality management system cover?
For more information about this conference visit https://www.researchandmarkets.com/research/xgbl8w/quality_audits View source version on businesswire.com: http://www.businesswire.com/news/home/20171122005526/en/ |