Barger achieves ISO 13485 certification

Medical and pharmaceutical packaging designer and manufacturer’s achievement communicates commitment to meeting medical device and component manufacturers’ quality standards for packaging.

Barger designs and manufactures sterile and nonsterile packaging for medical device applications.
Barger designs and manufactures sterile and nonsterile packaging for medical device applications.

Medical and pharmaceutical packaging designer and manufacturer Barger meet strict international and customer quality management system (QMS) requirements, as demonstrated by the 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 cleanrooms and nonsterile medical device packaging that comply with ISO globally recognized QMS standards represents a tremendous achievement and is 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 Corp., Barger has continued to expand its capabilities as a world-class designer and manufacturer of innovative medical device packaging systems.

Hollister says, “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.

Barger is an ISO 9001 and 13485-certified designer and manufacturer of custom medical device and component packaging systems. From design, prototyping, tooling to thermoforming, Barger produces world-class, turnkey nonsterile and sterile barrier packaging systems that help device and pharmaceutical manufacturers get products to market quickly, safely and cost-effectively. For more information, visit

Placon is a 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. Placon provides clamshells, protective thermoformed and injection-molded packaging products.

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