February 2016

Covestro Regulatory Support for Medical Applications

Covestro medical-grade products are used in a wide variety of health care applications. We are committed to providing our customers excellent regulatory support as they develop innovative medical products. These products usually require approval by the FDA Center for Devices and Radiological Health (CDRH) or Center for Drug Evaluation and Research (CDER). To assist our customers through the approval process, Covestro provides documentation and compliance statements to meet each customer’s individual requirements, such as:

  • ISO Manufacturing Certifications
  • ISO 10993 and USP Class VI biocompatibility statements
  • Physicochemical testing
  • FDA food-contact statements
  • Master file letters of authorization
  • BSE/TSE statements
  • Kosher/Halal statements
  • REACH/RoHS compliance statement
  • Allergen statement
  • Safety data sheets

Additional documentation may be available.

Covestro medical-grade products are produced using enhanced quality measures according to Good Manufacturing Practice (GMP) principles and have locked formulations subject to strict management of change policies.  Please contact your Covestro account manager or the Product Safety and Regulatory Affairs group in Pittsburgh for more information or to request regulatory support.

For more information, visit https://solutions.covestro.com/en/materials/plastics or email plastics@covestro.com.

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