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Preparing for unannounced EU regulatory inspections – are you ready?

This article was originally published in Clinica

Executive Summary

Unannounced visits from notified bodies are going to be part of life for medtech manufacturers in the EU. But do you know how you would cope if two inspectors walked through the door, expected your staff to host the visit and your testing equipment to be dedicated for their immediate use? Do you know what costs you would have to bear? Here, Gert Bos* and Francoise Schlemmer* of notified body association TEAM-NB explain why it is critical that manufacturers and subcontractors practice and validate protocols for hosting such visits

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