ClearCanvas PACS/RIS open source Radiology software is now ISO 13485:2003 certified. The ISO 13485:2003 certification specifies as per their website:
“ISO 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
As per ClearCanvas’ press release on their website they are also going to strive for further certification to allow their products to be used legally in the US & Canada.
“We've always taken pride in creating top quality software and this makes it official. In the coming months, we will be pursuing certifications from various regulatory bodies as well, including Health Canada and the FDA, so please stay tuned!”
Well done to the ClearCanvas guys again for pushing the open source radiology software 1 step closer to being a reality for everyone! Keep up the good work and we are eagerly awaiting future news and software releases.
