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Compliance and Quality

At Polymer Science, it is our goal to provide the highest quality product for your medical grade application by ensuring our manufacturing processes meet the range of regulatory boundaries that your products touch.

 

Polymer Science integrates a total quality management system into each and every product that we manufacture. Polymer Science is registered to ISO 9001:2015 and ISO 13485:2016. We are also compliant with ISO 10993 (ISO 10993-10, ISO 10993-5, and ISO 10993-1) regarding skin sensitization and irritation. Our registrar is internationally recognized BSI. Quality standards are audited internally and by a 3rd party registrar to ensure that each product is manufactured with our customers’ regulatory requirements in mind. We are cGMP compliant and registered with the FDA as a medical device and OTC drug manufacturer.



Certification of Regulations


To view our FDA registration page:

  • Visit the following link:  FDA Registration Search
  • Type in the establishment name:  Polymer Science, Inc
  • Click RETURN or ENTER


Materials Testing


In the Polymer Science testing lab, we provide a range of physical and biocompatibility test results on our materials to ensure they meet the form, fit and function requirements of your project specifications. This information is available in our technical data sheets or upon request.