Regulatory and QA
Full Quality Assurance certification (ISO 9001:2008, ISO 13485:2003, CAN/CSA ISO 13485:2003) has been obtained for the "design, manufacturing, sales and distribution of medical devices for open and laparoscopic vascular procedures".
CE audit was done by KEMA as Notified Body, and the CE certificate was received in June 2009.
The certification in Italy, Canada and Poland is in progress.
The certification in Italy, Canada and Poland is in progress.
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