Launch of AFNOR Spec 2311: A Reference Framework for Electronic Components in Active Implantable Medical Devices

Tame-Care is proud to announce the launch of AFNOR Spec 2311, a reference document developed in collaboration with key industry stakeholders. This specification aims to define and structure best practices for qualifying electronic components integrated or intended to be integrated into active implantable medical devices (AIMDs).

Resulting from a collective effort between component manufacturers, AIMD producers, technical experts, and regulatory bodies, AFNOR Spec 2311 addresses the growing need for structure and harmonization in this highly regulated and technologically demanding field.

It provides manufacturers with a valuable tool to facilitate component sourcing, manage risks, and accelerate device development.

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