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ISO 13485 Quality Management System For Medical Devices

ISO 13485 is the International standard for Quality Management System For Medical Devices.ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement.

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Why do I need it?

ISO 13485 standard provides a way to reduce variation. Reducing variation can provide financial benefits for the company, such as reduced scrap and general process efficiencies.

ISO 13485 purchasing requirements cover purchasing from qualified suppliers, according to pre-established specifications, and assuring that purchased product meets those specifications.

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Why do I need Veave Technologies in particular?

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Because we keep the entire process hassle-free, ISO 13485 Certification can take just 7 - 30 days to complete based on your company's size. In fact, our 'Keep it simple' approach means we can:

  • Reduce the time taken to acquire ISO 13485 Certification
  • Cut the cost of Certification
  • We provide you access to web based On line Process Repository Software to manage your complete process documentation
  • 24/7 access to our back end support team who can manage your process documentation remotely
  • Reduce management time required
  • Reduce the cost of maintaining Certification

Benefits of ISO 13485 Certification

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