MINNEAPOLIS—Precision Associates Inc. has earned ISO 13485:2016 certification for its medical device production.

To achieve this certification for a quality management system specific to the medical device industry, the provider of sealing solutions and precision-molded rubber products had to meet best practice requirements in each step of a product's life cycle, including manufacturing, service and delivery, according to the company's Feb. 6 news release. Insert Injection Molding

"Earning ISO 13485:2016 certification is a valuable achievement," said Bridget Hanson, vice president of sales and marketing at PAI. "It is a testament to PAI's commitment to the highest safety and quality standards for medical device contract manufacturing."

PAI recently expanded its 130,000-sq.-ft. clean room to support the growing demand for the company's rubber parts manufacturing. This ISO certification, it added, further supports this growth, adding that it also supports its liquid silicone rubber injection molding capabilities.

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