The Design and Manufacture of Medical Devices (ISO 13485)

An organisation within the medical device industry must implement the ISO 1348: 2003 into their quality management system to demonstrate their commitment to provide internationally acceptable models fit for customer, regulatory and other related service requirements.

The primary focus of the standard is to help medical device manufacturers, regardless of size or type of organisation, meet the regulations required of their field and implement a consistent quality management system.

ISO 13485 certification enables medical device manufacturers to:

  • Access worldwide markets otherwise unattainable
  • Outline how to review and improve processes across your organisation
  • Cut down costs, increase efficiency and monitor supply chain performance
  • Easily demonstrate that your medical devices are safer and more effective
  • Easily meet regulatory requirements and enhance customer satisfaction

IQC is a registered issuer of certificates of compliance when the satisfactory compliance standards and documented procedures are met.

Click here to enquire about the ISO 13485.

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