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ISO 13485: 2016


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Does Your Medical Cart Manufacturer Need to be ISO 13485-Certified?

Posted by Mary Kahler on October 7, 2021

In 2018, the FDA announced the intent to “harmonize” their Quality System Regulations with ISO 13485:2016 for medical devices to streamline requirements for QSR and modernize the regulation. With the changes that have...

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Topics: ISO Certification

New ISO 13485:2016 and ISO 9001:2015 Certificates: Changes You Can Expect from Your Manufacturer

Posted by Shannon Pelky on August 21, 2018

HUI is excited to announce that in June of 2018, we officially upgraded our quality management system to the new editions of ISO 9001 and ISO 13485. We are now ISO 9001:2015 and ISO 13485:2016 certified! This is great...

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Topics: ISO Certification, Industry Insights, Quality, News

The Value of Working with ISO 9001 Certified Suppliers

Posted by Shannon Pelky on March 29, 2018

You may have noticed that we proudly display our ISO 13485 and ISO 9001 certification at the top of almost every page on our website, but you might not understand why we put so much value on these certificates. In...

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Topics: ISO Certification, Quality

Evaluate Custom Medical Cart Manufacturer for Effective Supply Quality

Posted by Brittany Beckmann on January 19, 2017

Now that we have an understanding of what your company needs in order to have a successful custom medical cart project, we can delve into how your suppler quality management contributes to this process. 

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Topics: ISO Certification, Industry Insights, Quality

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