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EU's NBOG (Notified Bodies Operations Group) set to review design documentation requirements

This article was originally published in Clinica

Executive Summary

The EU Notified Bodies Operations Group (NBOG) has agreed to develop a "meddev" guidance document explaining the new requirements concerning quality system audits to assess the design documentation of products on a representative basis which are being introduced in the context of the review of the Medical Devices Directive (MDD).

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