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ISO 13485:2003 Medical

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OVERVIEW of ISO 13485:2003 Medical

In addition to Rochling's ISO 9001:2008 certification, they are now also ISO 13485:2003 Certified.
Röchling Engineering Plastics is the only manufacturer in the U.S. to be ISO 13485:2003 certified that supplies our broad product offering of engineering plastic stock shapes to the medical market.
  • Professional Plastics is a Master Distribution Partner to Rochling for their Medical Grade Plastic Shapes.
    ISO 13485:2003 represents the requirements for a comprehensive management system for the design and manufacturing of medical devices including:
  • Controls to ensure product safety
  • Risk management activities
  • Inspection and traceability
  • Documentation and validation of processes
  • Verification of the effectiveness of corrective and preventive actions
  • ISO 13485:2016 Certificate
  • Iso 13485:2003 Medical
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