ExpertiseUpdated on 9 September 2025
CE Marking and ISO 13485 certification
Medical Devices – Regulatory Services at BSI Notified Body at BSI Group Iberia
Madrid, Spain
About
Why choose BSI for your CE marking approval?
BSI Netherlands (2797) is a full-scope Notified Body designated for all types of products under the MDR:
-
General medical devices
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Active implantable medical devices
As a manufacturer, this simplifies the certification of your medical devices and saves you from having to manage your product portfolio across multiple Notified Bodies.
Our team has a unique set of expertise that enables us to provide a rigorous review of your technical documentation. You will be assigned a dedicated BSI Program Manager, who will work with you throughout the entire certification process and remain your main point of contact thereafter.
Field
- Healthcare
Organisation
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