Barger Demonstrates Quality Excellence with ISO 13485 Certification

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Achievement communicates Barger’s ongoing commitment to meeting medical device and component manufacturers’ rigorous quality standards for packaging.

ISO 13485 certification, ISO 9001 certified, medical packaging certification

Barger's Elkhart facility is 100% focused on medical packaging and is ISO 9001 / 13485 certified

Receiving ISO 13485 certification...acknowledges our commitment to producing innovative, safe and reliable packaging systems that consistently meet and exceed customer requirements.

A leading pharmaceutical and medical packaging designer and manufacturer, Barger has proven its ability to meet strict international, as well as customer, quality management system (QMS) requirements with its recent ISO 13485 certification of its Elkhart, IN facility. Awarded by American Systems Registrar (ASR), the certification supplements Barger’s existing ISO 9001:2008 quality system which was concurrently audited by ASR.

Producing both sterile packaging in Class 8 clean rooms and non-sterile medical device packaging that comply with ISO globally recognized QMS standards has been a tremendous achievement and critical to Barger’s continued growth and expansion. According to Shane Hollister, quality manager at Barger, “Receiving ISO 13485 certification has been a thoughtful investment and natural progression that acknowledges our commitment to producing innovative, safe and reliable packaging systems that consistently meet and exceed customer requirements.”

Since the 2011 acquisition by Placon Corporation, Barger has continued to expand its capabilities as a world-class designer and manufacturer of innovative medical device packaging systems. Continues Hollister, “Although it’s not a specified requirement, we believe ISO 13485 certification gives new and existing customers alike even greater confidence in our quality management system and end products.”

The certifications are specified to cover Barger’s design and manufacture of medical packaging which includes the company’s thermoforming, welding, die cutting and flexographic printing capabilities.

ABOUT BARGER
Barger, a division of Placon, is an ISO 9001 and 13485 certified, leading designer and manufacturer of custom medical device and component packaging systems. From innovative design, prototyping, tooling to thermoforming, Barger produces world-class, turnkey non-sterile and sterile barrier packaging systems that help device and pharmaceutical manufacturers get products to market quickly, safely and cost-effectively.

ABOUT PLACON
For over 45 years Placon has been a leading custom and stock designer and manufacturer of plastic packaging for the food, retail and medical markets with a line of extruded, EcoStar®-branded rollstock manufactured from recycled PET bottles and thermoforms. Continuously setting the bar in plastic packaging solutions, Placon provides innovative custom retail, high-quality stock clamshell, protective thermoformed and injection molded food, and safe medical device packaging products that harness the power of tomorrow’s technology and design to solve customers’ challenges today. For more information, visit http://www.placon.com.

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Melissa Jacobson
Placon
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