Barger, a leading medical and pharmaceutical packaging designer and manufacturer, 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, Indiana 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 recognised 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.
Barger, a division of Placon, is an ISO 9001 and 13485 medical device packaging designer and thermoformer known for its high-touch, collaborative approach to business. Located strategically near Warsaw, IN, Barger has over 40 years of custom pharmaceutical and medical packaging experience from design, clean room prototyping, tooling and thermoforming. Regarded as one of the leading medical packaging thermoformers in North America, Barger creatively designs and produces turnkey, non-sterile and sterile barrier packaging systems out of its Madison, WI and Elkhart, IN facilities, getting OEM’s products to market quickly and cost-effectively.