ISO 13485 Consulting and Implementation for Medical Device Manufacturers


  • Why do we need ISO 13485 certification?
  • How will ISO 13485 certification benefit our company?
  • What is involved in the implementation process?

ISO 13485 is a quality system standard designed specifically for medical device companies. It is the most common path to meet the Quality Management System (QMS) medical device requirements in Europe, Canada, and Australia, and serves as the basis for QMS compliance in other countries like Japan, Korea, and Brazil.

How ISO 13485 certification benefits your company

If you manufacture or market a Class II or higher-risk classification device and sell it outside the US, you probably need to be ISO 13485 certified. Certification can also expand your market access and improve your company's profitability. Here are some of the long-term benefits of ISO 13485:

  • It is the de facto standard for global medical device QMS compliance for medical devices, and is a prerequisite for access to most major markets worldwide.
  • ISO 13485 certification requires commitment and effort to attain, so it gives you additional credibility with potential customers.
  • A refined QMS system will increase efficiency, enhance product quality, and improve customer service within your company.

We'll help you implement ISO 13485 or upgrade from ISO 9001

We focus solely on medical device and IVD companies, so we understand the unique needs and manufacturing scenarios of the industry. With local offices around the world, our team of experienced QA consultants has helped hundreds of medical device and IVD manufacturers achieve ISO 13485 certification. Here's how we can help you:

  • We will fully customize your ISO 13485 quality system to meet your specific needs and make sure you are ready for a certification audit.
  • Our ISO 13485 consulting and project management teams work closely with you to implement your QMS on time and on budget.
  • We can recommend qualified third-party testing and certification firms that specialize in your device category.
  • Emergo will perform on-site ISO 13485 training for your key employees as part of the implementation project.
  • Upgrading to ISO 13485:2016? See how we can help.

We guarantee you will pass your first ISO 13485 certification audit if you follow our plan.

Contact us for more information on our ISO 13485 consulting services.

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