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Prent Denmark Achieves ISO 13485 Certification

Prent Denmark—a leading custom thermoformer of medical device packaging throughout Europe—is now ISO 13485 certified for medical devices. 

The ISO 13485 certification builds on Prent’s strong QMS (Quality Management System) platform—where most of the ISO requirements for Medical Devices were already being met. Certification illustrates our dedication to supplying packaging fully compliant with international ISO requirements in the Medical Device sector, giving our customers further confidence in our processes.

Since 2010, Prent Denmark has been supplying thermoformed medical device packaging to companies throughout Europe. It’s a full service ISO 9001:2008 certified thermoforming center with Class 8 clean rooms, product design capabilities, quality assurance and state-of-the-art robotic thermoformers.