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News

CE marking for image transfer service

Sectra : 08 June, 2015  (New Product)
The Sectra Image Exchange Portal for the secure transfer of healthcare images and data has been CE marked
CE marking for image transfer service


Sectra’s service for the secure transfer of images and patient reports between hospitals, the Sectra Image Exchange Portal (Sectra IEP), has been CE marked. CE marking confirms that the product meets all the requirements of the European Medical Device Directive (MDD 93/42/EEC) and that Sectra IEP is clinically safe and effective for its intended purpose.



“Many suppliers choose not to CE mark this type of system for information exchange and administration in medical care,” says Torbjörn Kronander, President and CEO at Sectra.



“However, we believe it is very important that our products offer a high level of clinical safety. For example, Sectra was one of few suppliers that CE marked a radiology information system (RIS) when authorities and legislators understood that this type of system was gaining increasingly advanced functions with a significant potential impact on patient safety.”



CE marking activities stretch beyond development and also include validation, installation, user training, service, support and post-market surveillance (such as clinical incident management and clinical feedback).


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