Why Medical Device Certification is Important

Now, perhaps more than ever, people around the world need medical devices they can count on. In order to help fill that need, STEWART has been creating personal protective equipment (PPE) for people in the healthcare industry and beyond.

STEWART Industries is ISO 13485 certified, which means we are in the unique position to help during these crazy times.

Above and Beyond

Our team is capable of lending a hand with medical devices because of our strict quality standards and over 20 years of manufacturing experience. Still, to make sure our clients know exactly how we can help, we made the decision to get ISO 13485:2016 certified back in 2017.

It’s not a requirement to be ISO certified in order to create medical devices. Many companies just strive to meet ISO standards when they manufacture. When it comes to medical devices, our team didn’t want to phone it in, we went the extra mile to secure certification.

Quality Where It Counts

There’s no room for quality issues in any type of manufacturing, but this is especially true with medical devices.

Being ISO 13485:2016 certified means we’ve spent the time ensuring our processes and inspections meet quality standards throughout the lifecycle of a medical device. Our team  assists with sub assembly, supply chain management, quality assurance, and more. Throughout all of these steps, we hold ourselves to the meticulous ISO 13485:2016 standard. Why? Because STEWART Industries aims to be the ideal partner for medical device manufacturers who are looking for help meeting demand.

Processes in Action

Recently, STEWART Industries collaborated with Excelerant Consulting and Wytcote Technologies to manufacture and provide N95 masks and other personal protective equipment (PPE). We wanted to help stop the price gauging on these devices that has been costing healthcare organizations dearly during the COVID-19 outbreak.

Since we’re ISO 13485:2016 certified we have access to amazing supply chain solutions, and we were able to ship out millions of pieces of PPE throughout the United States in only a few weeks.

Our team is looking forward to helping more medical device manufacturers produce the pieces they need to help put a stop to COVID-19. If you need a supply chain or sub assembly partner, look no further. Let’s work together.

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