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ISO 13485 Consulting and Implementation for Medical Device Manufacturers

ANSWERED ON THIS PAGE:

  • 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. ISO 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.

Common questions:

Can Emergo issue our ISO 13485 certificate?
No - only accredited Notified Bodies/Registrars are authorized to audit and certify your company to the ISO 13485 standard.

How long does it take to achieve ISO 13485 certification if we have no system in place?
Implementation usually takes 4-6 months for companies with fewer than 50 employees. Larger firms with more than 50 employees and/or multiple locations require more written procedures and involve more people, so implementation usually takes 6-12 months. Complex manufacturing processes (example: sterilization) can also prolong the implementation process.

The timeframe for certification is also dependent upon the availability of Notified Body/Registrar auditors to audit and certify your company – in some markets it may take at least between 6 – 9 months to schedule an on-site audit so it is critical that these organizations be engaged as early as possible to verify their availability.

When will ISO 13485:2016 be mandatory?
March 1, 2019 is the end of the transition period for updating certificates to the new version. Manufacturers seeking ISO 13485 certification for the first time should implement systems and procedures that comply with new version requirements. Learn more about ISO 13485:2016.

 

Within the UL family of companies we provide a broad portfolio of offerings to all the Medical Device industries.  This includes certification, notified body and consultancy services In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our Brand and our customers brands UL is unable to provide consultancy services to Notified Body or MDSAP customers.  UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Read more about this.