Current travel restrictions, combined with the necessity to maintain regulatory certification programs, have driven certification bodies to find alternative methods of assessing the conformity of medical device manufacturers’ quality management systems (QMS). Various...
ISO 13485 :2016 : Medical Devices – Quality Management System – Regulatory requirements, is available since the 25th of February 2016. This standard should be published in national legislation before September 2016. The working group who has wrote this standard...
