Quality with a Purpose
  All  ISO  standards  are  reviewed  and  revised  regularly  to make sure they remain relevant to the marketplace.  ISO  13485:2016  responds  to  the  latest  QMS  practices,  reflecting  the  evolution  in  medical  device  technology  and changes in regulatory requirements and expectations.  Transasia is the first Indian IVD Company to receive the ICMED 13485 quality certificate in 2018 for indigenously manufactured medical devices.     ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. Designed to be used by organizations throughout the lifecycle of a medical device, from initial conception to production and post-production, it includes final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated servi...