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.