Business operations are conducted at Sectra AB in two business areas: Medical Systems and Secure Communication Systems.
Business functions shared between the business areas - e.g. tools, quality, regulatory affairs and internal IT - reside in the department of Operational Excellence and IT.
The quality management system conforms to the Quality Management System Standards SS-EN ISO 9001:2008, SS-EN ISO 13485:2003 and, for medical devices placed on the Canadian market, to ISO 13485:2003/CMDCAS.
All medical devices meet the provisions of the Medical Devices Directive 93/42/EEC.
All medical devices placed on the US market have obtained FDA market clearance.
The management system conforms with the Quality Management System Standard SS-EN ISO 9001:2008. The certificate is valid for "Sales, development, production, delivery and service of hardware and software products for secure communication systems".
All products and systems are designed according to ITSEC standard (Information Technology Security Evaluation Criteria).
The information security management system conforms to the standard SS-ISO/IEC 27001:2013.
Any product, service or technology described on this server may be subject of Intellectual Property Rights reserved by Sectra AB or any of its subsidiaries.
© 1994 - 2016 Sectra AB, Sweden. All rights reserved.
No parts of the Sectra web site may be reproduced, in any form or by any means, without permission in writing from Sectra AB, Sweden. However, any person is hereby authorized to copy, print and distribute any document published by Sectra on the sectra.com web site provided that:
Information on this server is provided "as is" without any warranty of any kind, either express or implied, including but not limited to, the implied warranties of merchantability, fitness for a particular purpose, or non-infringement. The information herein may include technical inaccuracies or typographical errors. Changes may periodically be made to the information and will be incorporated in new editions. Sectra AB may make improvements or changes in products described at any time without notice.
Contact information submitted to the Sectra web site will be handled confidentially. All contact information will be used solely for the purposes outlined in the corresponding form.
If you have any questions, please feel free to contact Sectra at one of the addresses listed on the Contact page.