ISO 13485 Certification Service For Medical Device Manufacturers

At International Quality Certification, we can provide the ISO 13485 certification service required for medical device manufacturers both for national as well as international certification.

As with this entire family of standards, all based on the ISO 9001 international standard, the goal is to voluntarily meet all recognized quality management standards in North America, Europe, Brazil, Australia, South Korea as well as Japan and many other countries. Through our ISO 13485 registration service, your company can display this ISO standard, which is recognized in the USA by the Good Manufacturing Practices quality management system.

The Industries Involved

Through ISO 13485 certification bodies companies and business that are involved in designing, developing and producing medical devices, as well as related products and services, have the opportunity to display their adherence to these standards.

Companies working in the field of the design, development and production of in vitro medical devices, implants and other types of medical devices wanting to do business internationally, particularly in the countries and areas listed above, will need to have this certification.

The Certification Process

By working with our ISO 13485 certification service, we will work with you to ensure your practices and standards are meeting those of the ISO standards. This includes the development of written policies for issues such as internal audit procedures, corrective and preventive actions, process and design controls, record controls and retention as well as accountability through all aspects of production.

There are many benefits to a company in using our ISO 13485 registration service. Companies obtaining this voluntary certification will be able to expand their markets, improve the efficiency of their production systems, and make their products to a higher quality with increased consistency.

Contact Us

To learn more about our services and how we can help your company achieve ISO 13485 certification, give us a call today at 440-372-0772.