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Intertek Medical Notified Body AB
Accredited by: SWEDAC
Intertek Medical Notified Body AB is a recognized certification body that specializes in the accreditation of medical devices. It operates under the standards established by ISO 13485:2016 for quality management systems specific to medical devices. The organization is located in Kista, Sweden, and plays a crucial role in supporting the compliance and safety of medical products in the market.
Box 1103 164 22 Kista
Certification Scopes (1)
ISO 13485
management systems certification
Swedish Board for Accreditation and Conformity Assessment
Sweden
The scope of Intertek Medical Notified Body AB includes certification of management systems and various active medical devices. This includes devices for imaging, radiation therapy, and other non-implantable medical devices, ensuring compliance with international safety and effectiveness standards.
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