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ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ISO 13485:2003 is a quality system standard designed specifically for medical device companies. It is the most commonly chosen path for companies 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 such as Japan, Korea, and Brazil.

Advantages of ISO 13485 certification

If you manufacture or market any Class II or higher risk classification device, and you sell it outside the US, most likely you will need to be ISO 13485 certified. ISO certification offers many benefits for medical device companies:

  • 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 effort to attain and maintain, so it gives you additional credibility and legitimacy with potential customers.
  • Increased efficiency, better product quality and improved customer service within your company.
  • Your commitment to quality will be evident to your consumers and partners

Let us help you implement ISO 13485 or upgrade from ISO 9001

  • With local offices located worldwide, our team of experienced QA consultants has helped hundreds of medical device and IVD manufacturers achieve ISO 13485 certification. We focus solely on medical device and IVD companies so we understand the unique needs and manufacturing scenarios of the industry. Here’s how we can help: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 will work closely with you to ensure that your QMS is implemented on time and on budget.
  • We can recommend a number of qualified third-party testing and certification firms that specialize in your category of devices.
  • Emergo will perform on-site ISO 13485 training for your key employees as part of the implementation project.
  • Interested in 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!

Please contact us for more information on our ISO 13485 consulting services.


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Commonly asked questions:

Can you issue me an ISO 13485 certificate?
No - only accredited ISO Registrars are authorized to audit and certify your company to the ISO 13485 standard. Consulting performed by these Registrars would be a conflict of interest.

Should we certify to ISO 13485:2003 or ISO 13485:2016?
Companies that opt to certify to 2003 now should note that European Notified Bodies will not issue ISO 13485:2003 certificates after March 2018. Therefore, companies that obtain ISO 13485:2003 by January 1, 2017, for example, will only have a certificate that’s valid until March 2019. After this date, companies must obtain certification under ISO 13485:2016.