NSF Health Sciences

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Preparing for Unannounced Inspections from Notified Bodies

NSF Health Sciences

Vice-president of Europe-health sciences medical devices at NSF International has offered advice on how to prepare for unannounced audits by notified bodies after Europe introduces further measures.

There are two important documents that are concerned with unannounced inspections, the European Commission (EC) recommendation of September 24, 2013 concerning unannounced audits by notified bodies in the field of medical devices, and Team NB's Code of Conduct for Notified Bodies version 3.0 October 2012, Pages 21-23.

Unannounced inspections are already being undertaken by notified bodies and competent authorities are preparing for them to become mainstream by early 2014. Consider the following steps to ensure that you are prepared for EU notified body unannounced inspection

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