Bi-Link raises medtech profile with ISO 13485 certification, cleanroom molding in Mexico


A global supplier operating manufacturing facilities in the United States, Mexico and China, Bi-Link (Bloomingdale, IL) has been providing contract services to medical device OEMs for more than a decade. Offering prototyping, injection molding, metal stamping and assembly services to the medical as well as automotive and consumer markets, the company recently announced that its Bloomingdale and Juarez, Mexico, facilities have achieved ISO 13485 certification, the international quality standard for medical manufacturing.

Initially, Bi-Link supplied primarily electrical components and metal stampings to customers in the medtech space, which did not require ISO 13485 certification. But about four years ago, it achieved ISO 13485 certification for its Shanghai plant, says Terri Marion, Medical Segment Marketing Manager. That became a necessity as the company began supplying Tier 1 medical device OEMs. "As our relationships with global medical device OEMs expanded and deepened, it became increasingly important to have standardized practices and capabilities at all of our manufacturing plants," Marion told PlasticsToday. Bi-Link is generally demand-driven with regards to certifications, she added, and as a longtime supplier to the auto industry, the company has ISO 9001 and ISO TS 16949 certification at all of its facilities, she added.

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