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What are the benefits of ISO 13485 certification?

Some specialist sectors have quality management requirements that go beyond ISO 9001 and merit a standard of their own. ISO 13485 is an international quality management standard used by organisations involved in the design, manufacture, installation, and servicing of medical devices.

ISO 13485 certification offers specific benefits for medical device businesses, including:

  • Improved compliance with Medical Device Regulation (MDR):
    MDR is the European regulation governing the manufacture and sale of medical devices in the European Union. ISO 13485 certification is a recognised way to demonstrate compliance with many of the regulation's requirements.
  • Increased customer confidence and trust:
    Customers are more likely to do business with medical device companies that are ISO 13485 certified. Certification demonstrates commitment to quality and patient safety.
  • Reduced risk of recalls:
    ISO 13485 helps companies to identify and eliminate potential risks to product quality and safety, reducing the risk of costly and reputation-damaging recalls.
  • Improved efficiency and productivity:
    A well-implemented QMS can help companies to improve their efficiency and productivity by streamlining processes and reducing waste.
  • Reduced costs: By improving quality and reducing the risk of errors, ISO 13485 can help companies to reduce their overall costs.

In addition to these general benefits, ISO 13485 certification can also help medical device businesses to:

    • Expand into new markets:
      Countries participating in the Medical Device Single Audit Program (MDSAP) such as Australia, Canada, and Japan require medical device companies to be ISO 13485 certified in order to sell their products in those markets.
    • Improve their competitive advantage:
      ISO 13485 certification can help medical device companies to stand out from their competitors and attract new customers.
    • Increase their chances of winning government contracts:
      Many governments require medical device companies to be ISO 13485 certified in order to bid on government contracts.

      Learn more about the other ISO standards we offer to support the growth and success of your business.