FlexDex Surgical is proud to announce that it has received certification from National Standards Authority of Ireland (NSAI) that its Quality Management System conforms to the requirements of the EN ISO 13485:2012 Medical Device Manufacturing standard.
To achieve this milestone, FlexDex Surgical demonstrated that all of its activities conform to both the ISO standard and the current good manufacturing practices required by federal and international medical device regulations. To this end, the company was subjected to a pre-assessment readiness review followed by a thorough two stage certification audit, both of which were conducted by NSAI, an internationally recognized ANAB accredited certification body.
EN ISO 13485:2012 is an internationally recognized standard built on the foundation of ISO 9001 that has been enhanced to meet the stringent regulations and demanding requirements of the medical device industry. It is more prescriptive and requires a more thoroughly documented Quality Management System than the generic ISO 9001 standard.
FlexDex’s platform technology precisely translates the surgeon’s hand, wrist, and arm movements from outside the patient into corresponding movements of an end-effector inside the patient’s body. Based on a simple, purely mechanical, and affordable design, FlexDex greatly enhances the capabilities of all MIS instruments and endoscopes.
For more information visit www.FlexDex.com