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05 Sep 2010 
Welcome to Polymer Science, Inc. » News » ISO 13485 Registration
 ISO 13485 Registration
Posted By: John Biddle On: 25 Mar 2010 05:40 AM
Details Polymer Science has recently been audited and is now registered to ISO 13485:2003.

Polymer Science is now registered to ISO 13485:2003.  ISO 13485 is the ISO standard published to represent the harmonized requirements for a comprehensive management system for the design and manufacture of medical devices.

Polymer Science was already registered to ISO 9001, the latest edition published in 2008.  ISO 13485:2003 complements the requirements of the current ISO 9001 standard in that it demonstrates compliance to a documented quality management system, but has the fundamental difference in that it requires the quality system is implemented and maintained.  ISO 9001 has the additional requirement that an organization demonstrate continuous improvement which in part could be detrimental to form, fit or functionality requirements of validated and/or approved medical device components.  ISO 13485 goes further to promote awareness of regulatory requirements throughout the organization such as those defined in 21 CFR 820, Quality System Regulation for Medical Devices.  It also focuses on product effectiveness and safety which are determined as part of risk management and design transfer activities during the product development cycle.

Polymer Science currently manufactures products or components which are used extensively in the advanced wound care, consumer health care, diagnostic, ostomy and incontinence care markets which has bolstered the support of registration to this standard.  Our engineering and quality team is excited to put our experience and expertise in this field to work for you.

If you have any additional questions about our products, capabilities, certifications or services we can provide, please contact us.



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