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18 Sept 2025 | Madrid, Spain

ExpertiseUpdated on 9 September 2025

CE Marking and ISO 13485 certification

Pilar Maldonado

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

  • 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

BSI Group Iberia

Other

Madrid, Spain

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