ISO 13485 Certification for Companies that are ISO 9001 Certified

If you are a manufacturer, or supplier to medical device manufacturers, that currently has ISO 9001 certification, and you now need to achieve compliance with ISO 13485, we can help. This is quite common for companies who want to introduce existing products for use in medical applications or have broadened their product offerings that include medical device applications.

Although similar in the respect that they are both implementions of a quality management system, ISO 9001 and ISO 13485 have significant differences. ISO 9001 was developed for application to any industry, but ISO 13485 is specifically tailored to medical device companies. It is the most common path to QMS compliance for firms registering their medical devices in Europe, Canada, Japan, Australia and other markets.

If your current quality management system (QMS) complies with ISO 9001 and you need to move to or add ISO 13485, Emergo has the expertise to support upgrading your QMS for ISO 13485 compliance.

Let us help you add ISO 13485 in addition to your ISO 9001 certification

With offices in North and South America, Europe, the Middle East, Asia and Australia, Emergo has assisted hundreds of medical device companies with ISO 13485 QMS compliance.

For quality system upgrade projects, we don’t start from scratch. Instead, we build upon your existing ISO 9001 system, and add specific procedures necessary to comply with ISO 13485, saving you time and money. Emergo can also add processes and procedures as needed in order to develop a QMS that fully complies with ISO 13485 and also meets specific requirements you must meet to sell in markets such as Europe, Canada, South Korea and Japan. We will also make sure your QMS is in compliance with the US FDA Quality System Regulation found in 21 CFR Part 820.

The benefits of upgrading your QMS from ISO 9001 to ISO 13485 using Emergo as your consulting partner

  • We specialize in medical device compliance for manufacturers, service organizations, contract manufacturers and suppliers.
  • We have assisted hundreds of medical device companies with QMS implementation and auditing, including ISO 9001 to ISO 13485 conversions.
  • An Emergo quality system not only complies with ISO 13485, but can also be developed to meet medical device regulatory requirements in Europe, Australia, Japan, Canada and the US. We can also ensure you are in compliance with Brazilian GMP and Korean GMP as desired.

Please contact us for more information on upgrading your QMS from ISO 9001 to ISO 13485.

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