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ISO 13485:2003 QMS

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ISO 13485:2003 Qualoity Management SYstems

ISO 13485 Quality Management Systems

  • Manufacturing or sell medical devices?

  • Plan to sell your products in the Europe or Canada?

  • Need to comply with the US FDA QSR?

  • Need to improve field action and customer complaint processes?

  • Wish you could do things right the first time?

We can help! Quality Works assisted dozens of companies around the World in establishing and implementing effective ISO 13485:2003 Quality Management Systems. ISO 13485 is a quality management system standard designed specifically for medical device manufacturers. A Quality Management System compliant with the standard is mandatory for a number of classes of medical devices in Europe and Canada. The ISO 13485:2003 is based on ISO 9001:2000 standard, and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, traceability, compliance with regulatory requirements and others. Check our Products page to see how our documentation sets can help you in developing your Quality Management System or call us for a free, no obligation consultation. We can help!

Call us today to discuss your specific ISO management system needs!

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