Indilab, Inc. Earns ISO 13485:2003 Certification

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August 28, 2013: Indilab, Inc. earns ISO 13485:2003 certification for U.S. manufacturing facility in Franklin Park, IL.

Our focus is on developing and maintaining cost-effective, long-term sterilization solutions.

Indilab’s ISO 13485:2003 registration audit was conducted by Perry Johnson Registrars, Inc. and the site was certified for the Design, Manufacture, and Distribution of Process Sterilization Indicators for Medical Device Sterilization.

ISO 13485:2003 certification specifies processes for an organization's quality management system to demonstrate its ability to provide medical devices and related services that consistently meet regulatory and customer requirements pertaining to medical device application standards.

At Indilab’s Franklin Park plant, the company manufactures chemical sterilization indicator products for medical and dental devices and healthcare product manufacturers. Sterilization indicators assist with monitoring and evaluation of sterilization processes.

By producing these components to the stringent requirements set by ISO 13485:2003, the company continues to demonstrate its commitment to the medical industry.

Indilab is a trusted manufacturer of sterilization chemical indicator products for medical and dental devices and healthcare product manufacturers. We actively assist medical device manufacturers in the development of new technologies to better serve their customers. Indilab additionally manufacturers proprietary branded products used in conjunction with sterilization processes.

Our experienced design team can assist you with outsourcing, private-labeling or developing new process indicators or indicator applications for steam, ethylene oxide and hydrogen peroxide plasma sterilization systems.

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Robert Gavrick
Indilab, Inc.
+1 (800) 441-5000 Ext: 11
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Brynn Ray
Indilab, Inc.
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Indilab, Inc.
since: 08/2012
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