ISO 13485 For Medical Device

Rami.Azulay March 2nd, 2011 Posted by Rami Azulay( ) ISO 13485, Software Lifecycle Management

SO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Source: http://www.iso.org/iso/catalogue_detail?csnumber=36786


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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