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 and TickIT. 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 management system conforms to the standard SS-ISO/IEC 27001:2006.
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.
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