Barger, Placon’s Medical Division, Demonstrates Quality Excellence with ISO 13485 Certification

January 15, 2015
Barger is 100% medical packaging focused, designing and manufacturing products like this sterile thin-gauge thermoformed device tray

A leading medical and pharmaceutical 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 thin-gauge thermoforming, welding, die cutting and flexographic printing capabilities.

For 55 years, Placon has been a leading designer and manufacturer of custom and stock plastic packaging for the food, medical, and retail markets. Placon has manufacturing operations in Madison, WI; Elkhart, IN; Plymouth, MN; and West Springfield, MA, and currently ranked in Plastics News 2020 Thermoformers Ranking Top 20. Placon delivers packaging breakthroughs that inspire better engagement between people and products with industry leading innovation and award-winning packaging designs. For more information, visit