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You are here: Home / Nerac Insights / Articles / Notified Body Audits: Big Changes – Big Headaches

Notified Body Audits: Big Changes – Big Headaches

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By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: December 15th, 2014

The new Regulatory Framework for medical devices currently being considered in the European Union will no doubt bring about many significant changes to manufacturers. These changes will encompass stringent Notified Body requirements and oversight coupled with increasing Notified Body authority.  These changes will in turn affect your audit experience.

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