En iso 134852012 for software11/3/2023 ![]() ![]() ![]() 1882/2003 98/79/EC EU Council Directive of 27 October 1998 on in vitro diagnostic medical devices, as amended by EC regulation No. Checklist - Evaluation and Audit of Quality Systems Quality System Assessment Checklist DS/EN ISO 9001:2008 + AC:2009/2010 : Quality management systems – Requirements (EN ISO 9001:2008 + AC:2009) DS/EN ISO 13485:2012 : Medical devices – Quality management systems – Requirements for regulatory purposes (EN ISO 13485:2012) DS/CEN ISO/TR 14969:2005 Medical devices – Quality management systems – Guidance on the application of ISO 13485:2003 (CEN ISO/TR 14969:2004) 93/42/EEC : EU Council Directive of 14 June 1993 concerning medical devices, as amended by 98/79/EC, 2000/70/EC, 2001/104/EC, 2003/12/EC and 2007/47/EC and by EC regulation No.
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