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Consultants Over Notified Bodies? Manufacturers Losing Vital Resources With High Demand For EU Regulatory Experts

 
• By Amanda Maxwell

NSF Ireland recently withdrew its application for notified body status under the IVDR and MDR. Its reason? Demand among manufacturers for consultancy outweighs the need for another notified body. But aren't more notified body resources needed too?

There are not enough people who are skilled in applying medtech regulations, and there is huge demand to train and educate medical device and IVD manufacturers alike so that they can comply with the new Medical Device and IVD Regulations on time. That is the view of James Pink, who was recently named executive VP of consulting services at NSF International Medical Device.

Pink switched to his new role from his former position as head of notified body at NSF Certification Ireland as the organization announced that it pulled its application for designation...

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