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ISO 13485:2016

ISO 13485:2016

Whether you're looking to work internationally or expand locally, ISO 13485 Certification can assist you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

  • Increase access to more markets worldwide with certification.
  • Outline the way to review and improve processes across your organization.
  • Increase efficiency, cut costs and monitor supply chain performance.
  • Demonstrate that you simply produce safer and simpler medical devices.
  • Meet regulatory requirements and customer expectations.
  • By becoming certified within the ISO 13485 standard your company will:

  • Increase the probability of creating safe and effective medical devices
  • Meet regulatory requirements
  • Meet customer expectations
  • Help monitor the effectiveness of the availability chain
  • Enter any major market round the world with one audit.
  • Improved Risk Management and style Controls to help customers within the development and improvement of their products.
  • Improved efficiency in assisting customers obtains market clearance and approval to satisfy aggressive sales and marketing goals.