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...
Read MoreTopics: ISO Certification
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...
Read MoreTopics: ISO Certification, Industry Insights, Quality, News
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...
Read MoreTopics: ISO Certification, Quality
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.
Read MoreTopics: ISO Certification, Industry Insights, Quality
